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FOOD DRUG ADMINISTRATION [48 records]

Record 1 2026-04-28

English

Subject field(s)
  • Regulations and Standards (Food)
CONT

Among the claims that can be used on food and dietary supplement labels are three categories of claims that are defined by statute and/or FDA [Food and Drug Administration] regulations : health claims, nutrient content claims, and structure/function claims.

French

Domaine(s)
  • Réglementation et normalisation (Alimentation)
DEF

[...] message ou [...] représentation qui affirme, suggère ou implique qu'une denrée alimentaire possède des caractéristiques particulières.

CONT

Les allégations peuvent par exemple porter sur la présence ou l'absence de certains composants ou sur les qualités gustatives ou environnementales du produit.

Spanish

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Record 2 2025-06-27

English

Subject field(s)
  • Scientific Research
  • Immunology
CONT

... the Taiwan Food and Drug Administration(TFDA) designed a pathway to EUA [emergency use authorization] for all local vaccine candidates [against severe acute respiratory syndrome coronavirus 2] based on immunobridging, which compares the immune response of a vaccine candidate with an approved vaccine... It is assumed that a part of the immune response—such as binding or neutralizing antibodies—will correlate with other important components of the immune response... In the absence of efficacy data, immunobridging can be adopted as an approach to infer the likelihood of a vaccine's protective effect by translating immunogenicity to vaccine efficacy. The inference is based on the comparison of immunogenicity of a new vaccine with a comparator vaccine with an established protective effect...

Key term(s)
  • immuno-bridging

French

Domaine(s)
  • Recherche scientifique
  • Immunologie
DEF

Procédure de mise au point d'un vaccin qui est fondée sur l'évaluation de la production d'anticorps.

OBS

évaluation immunologique : désignation et définition publiées au Journal officiel de la République française le 19 juin 2024.

Spanish

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Record 3 2024-11-19

English

Subject field(s)
  • Pharmacy
DEF

[The process of] mixing together of two or more ingredients (of which at least one is a drug or pharmacologically active component) to create a final product in an appropriate form for dosing.

CONT

Compounding can use [drug products approved by the Food and Drug Administration(FDA) ] as a starting point, and alter them in some way, such as combining or diluting them. Compounding can also start with bulk substances(active pharmaceutical ingredients [APIs]) and combine them with excipients(inactive ingredients) to produce the final compounded preparation.

French

Domaine(s)
  • Pharmacie
DEF

[Processus qui consiste à mélanger] deux ingrédients ou plus (dont au moins un ingrédient est une drogue ou une composante pharmacologique active) pour créer un produit final sous forme dosifiée appropriée.

Spanish

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Record 4 2024-05-01

English

Subject field(s)
  • Chemical Elements and Compounds
  • Explosives and Pyrotechnical Materials (Industries)
  • Medication
Universal entry(ies)
CONT

Pentaerythritol tetranitrate is the nitrate ester of pentaerythritol that possesses explosive properties. When mixed with a plasticizer, this chemical forms a plastic explosive. It is recognized by the FDA [U. S.(United States) Food and Drug Administration] to be a coronary vasodilator in the treatment of heart conditions such as angina.

Key term(s)
  • nitropentaerythrityl

French

Domaine(s)
  • Éléments et composés chimiques
  • Explosifs et artifices (Industries)
  • Médicaments
Entrée(s) universelle(s)
CONT

Certaines molécules, telles que la nitroglycérine et la pentrite, sont utilisées comme médicaments ou comme explosifs.

Spanish

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Record 5 2023-05-12

English

Subject field(s)
  • Medication
CONT

Dobutamine is approved by the Food and Drug Administration(FDA) for short-term use in patients with decreased contractility due to heart failure or cardiac surgical procedures leading to cardiac decompensation.... Dobutamine is used as a pharmacological agent and has both inotropic and chronotropic effects depending on the dose..... Dobutamine's inotropic effect increases contractility, leading to decreased end-systolic volume and, therefore, increased stroke volume.

French

Domaine(s)
  • Médicaments
CONT

La dobutamine est indiquée dans toutes les classes d'âge pédiatriques (du nouveau-né à 18 ans) pour son effet inotrope positif dans les états d'hypo-perfusion par bas débit cardiaque, secondaires à une insuffisance cardiaque décompensée, une chirurgie cardiaque, une cardiomyopathie ou un choc cardiogénique ou septique.

Spanish

Campo(s) temático(s)
  • Medicamentos
Save record 5

Record 6 2020-09-01

English

Subject field(s)
  • Titles of Programs and Courses
  • Mollusks, Echinoderms and Prochordates
  • Crustaceans
OBS

The purpose of the NSSP is to promote and improve the sanitation of shellfish (oysters, clams, mussels and scallops) moving in interstate commerce through federal/state cooperation and uniformity of State shellfish programs.

OBS

Under international agreements with FDA [Food and Drug Administration], foreign governments also participate in the NSSP.

French

Domaine(s)
  • Titres de programmes et de cours
  • Mollusques, échinodermes et procordés
  • Crustacés

Spanish

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Record 7 2020-02-14

English

Subject field(s)
  • Informatics
  • Medical and Surgical Equipment
CONT

The Food and Drug Administration(FDA) is establishing a unique device identification(UDI) system to standardize and adequately identify medical devices through their distribution and use. When fully implemented, the label of most medical devices will include a unique device identifier in human and machine readable form. The unique device identifier is a unique set of alphanumeric codes consisting of both a device identifier(company and product code) and a production identifier(specific manufacturing information).

French

Domaine(s)
  • Informatique
  • Équipement médico-chirurgical
CONT

L'identifiant unique des dispositifs (IUD) permet d'assurer la traçabilité des dispositifs médicaux au travers d'un code international, unique et non ambigu, identifiant chaque dispositif médical (DM) tout au long de son cycle de vie.

Spanish

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Record 8 2019-06-20

English

Subject field(s)
  • Emergency Management
  • Risks and Threats (Security)
  • Collaboration with the FAO
CONT

In addition, regulatory initiatives of the U. S. [United States] Food and Drug Administration related to bioterrorism preparedness and implementing the provisions of the Bioterrorism Preparedness and Response Act of 2002 were highlighted, including Sections related to the Registration of Food Facilities, Establishment and Maintenance of Records, Prior Notice of Imported Food Shipments and Administrative Detention.

French

Domaine(s)
  • Gestion des urgences
  • Risques et menaces (Sécurité)
  • Collaboration avec la FAO
CONT

En outre, les initiatives de la Food and Drug Administration (FDA) liées à la préparation au bio-terrorisme et à la mise en œuvre des dispositions de la loi de préparation et de riposte au bio-terrorisme de 2002 ont été soulignées, notamment les sections concernant l'homologation des installations alimentaires, la création et la tenue à jour de fichiers, la notification préalable des cargaisons d'aliments importés et la détention administrative.

Spanish

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Record 9 2019-06-07

English

Subject field(s)
  • Pharmacology
  • Food Industries
  • Collaboration with the FAO
DEF

[The] parent drug together with all the metabolites and drug based products that remain in the food after administration of the drug to food producing animals.

French

Domaine(s)
  • Pharmacologie
  • Industrie de l'alimentation
  • Collaboration avec la FAO

Spanish

Save record 9

Record 10 2018-05-08

English

Subject field(s)
  • Food Additives
  • Regulations and Standards (Food)
CONT

A substance that will be added to food is subject to premarket approval by FDA [Food and Drug Administration] unless it is generally recognized, among qualified experts, to be safe under the conditions of its intended use(GRAS is the acronym for generally recognized as safe).

Key term(s)
  • generally recognised as safe

French

Domaine(s)
  • Additifs alimentaires
  • Réglementation et normalisation (Alimentation)

Spanish

Campo(s) temático(s)
  • Aditivos alimentarios
  • Reglamentación y normalización (Alimentación)
CONT

[...] los sorbatos, compuestos antimicrobianos, están tipificados como GRAS, sigla que le da al producto la patente de "generalmente reconocido como seguro" para la salud, pero no por ello dejan de ser sustancias artificiales, con todas las implicancias que ello tiene.

OBS

GRAS por sus siglas en inglés.

Save record 10

Record 11 2018-02-19

English

Subject field(s)
  • Government Bodies and Committees (Non-Canadian)
  • Regulations and Standards (Food)
  • Food Safety
OBS

The Food Safety Modernization Act(FSMA) was signed into law by President Barack Obama on January 4, 2011. The FSMA has given the Food and Drug Administration(FDA) new authorities to regulate the way foods are grown, harvested and processed.

Key term(s)
  • Food Safety Modernisation Act
  • FDA Food Safety Modernisation Act

French

Domaine(s)
  • Organismes et comités gouvernementaux non canadiens
  • Réglementation et normalisation (Alimentation)
  • Salubrité alimentaire
OBS

La règle de la loi FDA Food Safety Modernization Act (FSMA) [...] exige que les importateurs exécutent certaines activités [...] afin de vérifier que les denrées importées aux États-Unis ont été produites conformément aux normes américaines de sécurité applicables.

Key term(s)
  • Food Safety Modernisation Act
  • FDA Food Safety Modernisation Act

Spanish

Save record 11

Record 12 2017-07-13

English

Subject field(s)
  • Quality Control (Management)
  • Customer Relations
  • Special-Language Phraseology
CONT

Recalling firms are responsible for alerting FDA [Food and Drug Administration], their distributors, and users of the devices about the recall. The recalling firm provides instructions on steps to be taken to fix the device or advises parties to discontinue its use.

French

Domaine(s)
  • Contrôle de la qualité (Gestion)
  • Relations avec la clientèle
  • Phraséologie des langues de spécialité
CONT

[...] il se peut que l'ACIA [Agence canadienne d'inspection des aliments] ou l'entreprise effectuant le rappel ait à publier un second communiqué.

Spanish

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Record 13 2017-03-22

English

Subject field(s)
  • Drainage and Irrigation (Agric.)
  • Water Pollution
  • Food Safety
CONT

Recent outbreaks of foodborne illness have been linked to the consumption of contaminated sprouts. The spent irrigation water used to irrigate sprouts can carry many microorganisms, including pathogenic strains or Escherichia coli and Salmonella enterica. These pathogens are believed to originate from the seeds. The U. S. Food and Drug Administration recommends that sprout producers conduct microbiological testing of spent irrigation water from each production lot at least 48 h after seeds have germinated.

French

Domaine(s)
  • Drainage et irrigation (Agriculture)
  • Pollution de l'eau
  • Salubrité alimentaire
CONT

Durant la germination, il est essentiel de garder l'environnement et l'équipement propres, pour éviter toute contamination. Tout l'équipement doit être nettoyé et désinfecté avant la germination de chaque nouveau lot [...] Afin de déterminer si des microorganismes pathogènes sont présents dans le produit fini, il est recommandé de recueillir de l'eau d'irrigation usée après 48 heures de germination et de rechercher la présence de microorganismes pathogènes.

Spanish

Campo(s) temático(s)
  • Drenaje y riego (Agricultura)
  • Contaminación del agua
  • Inocuidad Alimentaria
Save record 13

Record 14 2014-12-19

English

Subject field(s)
  • Food Industries
  • Biotechnology
CONT

These occurrences include the introduction of new legislation requiring the special labeling of foods(including meat and poultry) produced by modern biotechnology(H. R. 3377, 1999) ;the spillover effects of the European debate about "Frankenstein" foods(Klee, 1999) and requisite European Union(EU) labeling requirements(EU, 1998) ;a suit against the Food and Drug Administration(FDA) demanding mandatory labeling, among other things(Alliance for Biointegrity v. Shalala, 1998) ;and three public hearings on the subject of biotech food labeling and other topics(FDA, 1999a).

French

Domaine(s)
  • Industrie de l'alimentation
  • Biotechnologie
CONT

[...] le conseiller scientifique du gouvernement britannique, le gouvernement lui-même, tous ont été singulièrement inefficaces et tous ont désastreusement sous-estimé les réactions du public à ce qui a fini par être connu, non sous le nom «aliments transgéniques», mais sous celui de «aliments Frankenstein».

Spanish

Campo(s) temático(s)
  • Industria alimentaria
  • Biotecnología
DEF

Alimento que contiene, está constituido o ha sido producido a partir de organismos cuyo material genético ha sido modificado.

CONT

Los organismos genéticamente modificados (OGM) pueden definirse como organismos en los cuales el material genético (ADN) ha sido alterado de un modo artificial. [...] la tecnología de ADN recombinante [...] permite transferir genes seleccionados individuales de un organismo a otro, también entre especies no relacionadas. Dichos métodos se utilizan para crear vegetales GM que luego se utilizan para desarrollar cultivos de alimentos GM. [...] ¿Por qué se producen alimentos GM? Los alimentos GM se desarrollan y comercializan porque se percibe cierta ventaja tanto para los productores como para los consumidores de estos alimentos.

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Record 15 2014-04-11

English

Subject field(s)
  • Immunology
  • Cancers and Oncology
  • Medication
DEF

A monoclonal antibody binding to the CTLA-4 expressed in activated T cells ...

OBS

[Ipilimumab] was recently approved by the U. S. Food and Drug Administration(FDA) for the treatment of metastatic melanoma.

French

Domaine(s)
  • Immunologie
  • Cancers et oncologie
  • Médicaments
DEF

Anticorps monoclonal se liant à la protéine CTLA-4 (cytotoxic T-lymphocyte antigen 4) [...]

CONT

[...] l'ipilimumab a reçu l'autorisation de la Commission européenne pour être administré en première ligne du traitement du mélanome avancé - non opérable ou métastatique.

CONT

En cas de mélanome, le récepteur lymphocytaire CTLA-4 est inhibé par les cellules cancéreuses, ce qui empêche les lymphocytes T de détruire les cellules tumorales au niveau ganglionnaire. L'ipilimumab fonctionne en débloquant ce mécanisme inhibiteur.

Spanish

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Record 16 2014-01-22

English

Subject field(s)
  • Pharmacology
  • Food Industries
DEF

A regulatory process and categorization whereby the United States Food and Drug Administration(FDA) authorizes specified use of an unapproved device in controlled settings for collecting data on the device's safety and theoretical or practical effectiveness.

OBS

The data thus collected may be used subsequently in a premarketing approval application.

OBS

investigational device exemption; IDE: term, abbreviation and definition standardized by the Health Technology Assessment (HTA) Glossary English Editorial Board and the Translation Bureau.

French

Domaine(s)
  • Pharmacologie
  • Industrie de l'alimentation
DEF

Processus et catégorisation réglementaires par lesquels la Food and Drug Administration (FDA) des États-Unis autorise l’usage spécifique d’un produit non approuvé, dans des milieux contrôlés, à des fins de collecte de données sur son innocuité et son efficacité théorique ou pratique.

OBS

Les données ainsi recueillies pourront ensuite être utilisées pour une demande d’autorisation de mise en marché.

OBS

exemption des dispositifs de recherche : terme et définition normalisés par l'Institut national d'excellence en santé et en services sociaux (INESSS) et le Bureau de la traduction.

Spanish

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Record 17 2014-01-07

English

Subject field(s)
  • Commercial Law
  • Marketing
  • General Medicine, Hygiene and Health
DEF

An application made by the manufacturer to the Food and Drug Administration(FDA) for approval to market a medical product in the United States.

OBS

This application includes the pertinent information documenting the safety and effectiveness of the product.

OBS

premarket approval application; PMA: term, abbreviation and definition standardized by the Health Technology Assessment (HTA) Glossary English Editorial Board and the Translation Bureau.

Key term(s)
  • pre-market approval application
  • pre-marketing approval application

French

Domaine(s)
  • Droit commercial
  • Commercialisation
  • Médecine générale, hygiène et santé
DEF

Demande d’approbation de la commercialisation d’un produit médical aux États-Unis présentée par le fabricant à la Food and Drug Administration (FDA).

OBS

demande d'autorisation de mise en marché; demande d'autorisation de mise sur le marché; demande d'approbation préalable à la mise en marché : termes et définition normalisés par l'Institut national d'excellence en santé et en services sociaux (INESSS) et le Bureau de la traduction.

Spanish

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Record 18 2013-03-08

English

Subject field(s)
  • Dyes and Pigments (Industries)
  • Regulations and Standards (Food)
  • Food Additives
DEF

Food coloring agents certified by the FDA(American Food and Drug Administration) ;they may be organic or inorganic, natural or synthetic, and must satisfy strict regulations as to toxicity.

CONT

Previous to 1959, the certified food colors were dyes only; that year, however, the lakes of the dyes were added to the list. Lakes are pigments. The present certified color additive list consists of two major classifications: dyes and lakes.

OBS

According to the law (especially in the U.S.A.), we should not confuse "permitted food color" and "certified food color." Some color additives (as carbon black) are permitted in food but are listed on the list of "uncertified food colors."

Key term(s)
  • certified food colour

French

Domaine(s)
  • Teintures et pigments (Industries)
  • Réglementation et normalisation (Alimentation)
  • Additifs alimentaires
DEF

Matière colorante, d'origine naturelle ou synthétique, dont la Loi permet l'utilisation comme additif alimentaire; cette autorisation est le plus souvent assortie de conditions relatives à l'innocuité du colorant, compte tenu de sa provenance, de sa composition, de l'étiquetage, etc.

OBS

Certains colorants alimentaires sont dits «tolérés» : l'industrie en fait usage alors même qu'ils n'ont pas été officiellement autorisés (et tant qu'ils ne sont pas l'objet d'une interdiction pure et simple).

Spanish

Campo(s) temático(s)
  • Tinturas y pigmentos (Industrias)
  • Reglamentación y normalización (Alimentación)
  • Aditivos alimentarios
CONT

Colorantes autorizados. Colorantes que pueden utilizarse en los productos alimenticios, así como sus condiciones de uso, se armonizan para proteger la salud de los consumidores e impedir que las diferencias en las legislaciones nacionales entorpezcan la libre circulación de los productos alimenticios.

CONT

Un colorante certificado implica que su pureza y composición están determinadas y avaladas por una autoridad competente, son consistentes en su potencia.

OBS

[Los] colorantes autorizados [...] se recogen en una lista que se actualiza con regularidad.

Save record 18

Record 19 2012-02-21

English

Subject field(s)
  • Fatty Substances (Food)
  • Chemical Elements and Compounds
  • Dietetics
DEF

An unsaturated fatty acid that contains one or more isolated or non-conjugated double bonds in a trans-configuration.

CONT

There are four major categories of dietary fat for labeling purposes : saturated, monounsaturated, polyunsaturated and trans fat. The FDA [Food and Drug Administration] considers the terms "trans fat" and "trans fatty acids" as interchangeable.

OBS

When listed on a Nutrition Facts panel, it must be termed "trans fat" and be declared directly below the amount of saturated fat. Listing unhealthy fats, such as saturated and trans fats, will be mandatory. Mono- and polyunsaturated fats, which are considered "healthy" fats, are voluntary nutrients. They may or may not be declared on a Nutrition Facts panel.

French

Domaine(s)
  • Corps gras (Ind. de l'aliment.)
  • Éléments et composés chimiques
  • Diététique
DEF

Acide gras insaturé qui contient une ou plusieurs liaisons doubles isolées ou non conjugées de configuration trans.

CONT

Les gras trans apparaissent lorsqu'on utilise un processus appelé hydrogénation, c'est-à-dire lorsque l'on transforme des huiles liquides en huiles solides. Ce procédé a pour effet d'augmenter la durée de vie et la stabilité du produit, mais également de former les gras trans.

Spanish

Campo(s) temático(s)
  • Substancias grasas (Industria alimentaria)
  • Elementos y compuestos químicos
  • Dietética
DEF

Ácido graso insaturado que ha sido parcialmente hidrogenado y se utiliza en los alimentos para aumentar su vida útil y mantener su sabor.

CONT

Los ácidos grasos trans, como las grasas saturadas y el colesterol dietético elevan el colesterol LDL (colesterol "malo") que incrementa el riesgo de insuficiencia coronaria. Los expertos en salud recomiendan mantener la ingesta de estos nutrientes lo más baja que sea posible al tiempo de consumir una dieta nutricionalmente adecuada.

OBS

Ficha realizada en colaboración con los estudiantes del Certificado en Traducción español-inglés del Glendon College, York University, Toronto, Canadá.

Save record 19

Record 20 2011-10-27

English

Subject field(s)
  • Medication
  • Cancers and Oncology
CONT

Paclitaxel(Taxol) is a compound originally isolated from the bark of the Pacific yew tree(Taxus brevifolia). It has been approved by the U. S. Food and Drug Administration(FDA) for treating breast and ovarian cancers as well as lung cancer and AIDS-related Kaposi's sarcoma.

French

Domaine(s)
  • Médicaments
  • Cancers et oncologie
CONT

La solution micellaire de paclitaxel est une version reformulée de l'ingrédient actif de Taxol md, médicament couramment employé contre le cancer.

Spanish

Campo(s) temático(s)
  • Medicamentos
  • Tipos de cáncer y oncología
Save record 20

Record 21 2011-08-10

English

Subject field(s)
  • Food Additives
  • Dietetics
  • Sugar Industry
CONT

Artificial sweeteners have been classified as nutritive and non-nutritive depending on whether they are a source of calories. ... The non-nutritive sweeteners, better known as artificial sweeteners, include substances from several different chemical classes that interact with taste receptors ...

CONT

Artificial sweeteners are sugar-substitutes. There are 2 kinds..., nutritive and non-nutritive. Nutritive sweeteners provide some calories, non-nutritive sweeteners typically provide zero calories.... Non-nutritive artificial sweeteners are intensely sweet-between 200-700 times sweeter than sugar. They add sweetness to foods for people(like diabetics) who need to limit their intake of sugar. They contain little or no calories or glycemic response(impact on blood sugar levels).... FDA [Food and Drug Administration] has approved 4 nonnutritive sweeteners and regulates them as food additives : saccharin(on an interim basis pending additional study), aspartame, acesulfame potassium(or acesulfame-K), and sucralose.

OBS

Non-nutritive sweeteners, also known as artificial or non-caloric sweeteners, are intensely sweet synthetic substances, often used to replace sugars in food manufacturing and cooking because they are calorie-free.

French

Domaine(s)
  • Additifs alimentaires
  • Diététique
  • Sucrerie (Industrie de l'alimentation)
CONT

Les édulcorants non nutritifs contiennent peu ou pas de kilojoules.

OBS

acalorique : Qui n'apporte pas de calories (à un organisme).

Spanish

Campo(s) temático(s)
  • Aditivos alimentarios
  • Dietética
  • Industria azucarera
DEF

Producto de alto poder edulcorante que proporciona cero calorías [...] se utiliza en las comidas como sustituto del azúcar de mesa y en productos [...] como yogures, postres, gaseosas, golosinas y productos horneados, entre otros.

Save record 21

Record 22 2011-01-21

English

Subject field(s)
  • Chemical Elements and Compounds
  • Food Additives
  • Pharmacology
Universal entry(ies)
C9H12N2O2
formula, see observation
C2H5O-C6H4-NH-CO-NH2
formula, see observation
150-69-6
CAS number
DEF

A chemical product which appears under the form of white, needle crystals or of a powder, which has a taste about two hundred times as sweet as sugar, which is derived from para-aminophenol, is used as an artificial sweetening agent and has been prohibited by the Food and Drug Administration(FDA) for use in foods.

OBS

(4-ethoxyphenyl)urea: form recommended by the IUPAC (International Union of Pure and Applied Chemistry).

OBS

This substance should not be confused with dulcitol.

OBS

Chemical formula: C9H12N2O2 or C2H5O-C6H4-NH-CO-NH2

French

Domaine(s)
  • Éléments et composés chimiques
  • Additifs alimentaires
  • Pharmacologie
Entrée(s) universelle(s)
C9H12N2O2
formula, see observation
C2H5O-C6H4-NH-CO-NH2
formula, see observation
150-69-6
CAS number
CONT

[La] dulcine [est un] produit synthétique dérivé de la phénétidine ayant un pouvoir sucrant analogue à celui de la saccharine (200 à 300 fois celui du saccharose). [...] Découverte en 1883, son usage alimentaire est interdit.

OBS

(4-éthoxyphényl)urée : forme recommandée par l'UICPA (Union internationale de chimie pure et appliquée).

OBS

Formule chimique : C9H12N2O2 ou C2H5O-C6H4-NH-CO-NH2

Spanish

Campo(s) temático(s)
  • Elementos y compuestos químicos
  • Aditivos alimentarios
  • Farmacología
Entrada(s) universal(es)
C9H12N2O2
formula, see observation
C2H5O-C6H4-NH-CO-NH2
formula, see observation
150-69-6
CAS number
DEF

Sólido cristalino blanco, 200 veces más dulce que la sacarosa. Soluble en alcohol y éter; poco soluble en agua caliente.

OBS

Fórmula química: C9H12N2O2 o C2H5O-C6H4-NH-CO-NH2

Save record 22

Record 23 2011-01-05

English

Subject field(s)
  • Diagnostic Procedures (Medicine)
DEF

A phthalic indicator dye that appears yellow-green in normal tear film and bright green in a more alkaline medium, such as the aqueous humor, and is used therapeutically as a diagnostic aid in corneal injuries and corneal trauma.

OBS

It has been approved by FDA [Food and Drug Administration] for use in externally applied drugs and cosmetics.

Key term(s)
  • fluorescein dye

French

Domaine(s)
  • Méthodes diagnostiques (Médecine)
DEF

Produit fluorescent, la fluorescéine (fluorescéinate de sodium) [...] permet de pratiquer l'angiographie rétinienne, afin de visualiser la rétine et la choroïde (membrane mince située entre la sclérotique et la rétine), et plus particulièrement leur vascularisation.

Spanish

Campo(s) temático(s)
  • Procedimientos diagnósticos (Medicina)
Save record 23

Record 24 2010-12-14

English

Subject field(s)
  • Trade Names
  • Medication
OBS

FDA [Food and Drug Administration] Advisory Committee Recommends First Pneumococcal Conjugate Vaccine For Children.... Pneumococcal 7-valent Conjugate Vaccine(Diphtheria CRM197 Protein) will be marketed as Prevenar(by Wyeth Lederle Vaccines, a unit of Wyeth-Ayerst Laboratories...

OBS

Prevenar: A trademark of Wyeth-Ayerst Laboratories.

French

Domaine(s)
  • Appellations commerciales
  • Médicaments
OBS

[Le] vaccin pneumococcique polysaccharidique conjugué à 7 valences [correspond] au Prevenar) [...]

OBS

Prevnar : Marque de commerce de la société Wyeth-Ayerst Laboratories.

Spanish

Save record 24

Record 25 2010-06-09

English

Subject field(s)
  • Injections, Tubing and Transfusions (Medicine)
CONT

A workshop sponsored by the Food and Drug Administration was held recently during which available data were reviewed concerning surrogate testing of blood donated for transfusion in order to reduce the risks of posttransfusion non-A, non-B hepatitis. Clinical studies from which the efficacy of testing for alanine aminotransferase and antibody to hepatitis B core antigen(anti-HBc) could be predicted indicated such testing would be useful...

French

Domaine(s)
  • Injections, tubages et transfusions (Médecine)
OBS

[...] Il n'existe pour le moment aucun test diagnostique permettant de détecter les sujets «porteurs sains». Le moyen indirect le plus fiable serait le dosage des alanine-transaminases.

Spanish

Save record 25

Record 26 2010-04-28

English

Subject field(s)
  • Packaging Techniques
CONT

Industry has adopted the term "tamper-evident" packaging, but there is no officially recognized definition for it. The United States Food and Drug Administration(FDA)... defines a "tamper-resistant" package as a package "having an indicator or barrier to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred. "Common industry usage substitutes the term "tamper-evident" for the term "tamper-resistant".... The FDA has not objected to this substitution, nor has it made any official recognition of it as a synonymous term.... [It] seems likely that use of both terms will continue for some time. All practitioners and the FDA are agreed that the term "tamper-proof" is not appropriate and must not be used.

French

Domaine(s)
  • Techniques d'emballage
DEF

Opérations visant à protéger, au moyen d'un indicateur d'effraction, un conditionnement unitaire.

OBS

En ce qui concerne les indicateurs d'effraction, la législation dans ce domaine est typiquement et uniquement américaine. (...) La législation américaine prévoit un certain nombre de bouchages et fermetures pour produits pharmaceutiques devant être exclusivement utilisés. Parmi eux se trouvent le blister-pack et l'enveloppage sous film et/ou bande plastique rétractable. Ce dernier procédé est aujourd'hui de loin, le plus utilisé, plus particulièrement sous forme de manchons qui incluent le contenant, bouteilles, tubes, flacons, et sa fermeture.

Spanish

Save record 26

Record 27 2010-03-05

English

Subject field(s)
  • Customs and Excise
CONT

The Bioterrorism Act's final rule on "Prior Notice of Imported Food Shipments" requires that notice of food shipments be confirmed electronically with the FDA [Food and Drug Administration] not more than five days or not fewer than 2 hours if imported by land, four hours by air or rail, or eight hours by water.

French

Domaine(s)
  • Douanes et accise
CONT

EXPRES vise les marchandises à faible risque importées par voie terrestre des États-Unis au Canada [...]

Spanish

Save record 27

Record 28 2009-06-12

English

Subject field(s)
  • Non-Surgical Treatment
  • Drugs and Drug Addiction
CONT

Short-term substitution therapy is used for opioid detoxification. Methadone, a long-acting opioid agonist... is approved by the FDA [Food and Drug Administration] for... short-term [narcotic] detoxification lasting up to 30 days... Protocol for methadone detoxification.... Start with methadone 10 mg as needed for withdrawal for the first 24 hours, with maximum daily dose of 40 mg.... assess the patient and start on once-a-day dosing, usually 30-40 mg... Dosage may be decreased by 5-10 mg/day...

French

Domaine(s)
  • Traitements non chirurgicaux
  • Drogues et toxicomanie
CONT

La désintoxication à la méthadone (sevrage à court terme) est abandonnée par la plupart des praticiens [...] au profit d'une substitution à moyen ou long terme (plusieurs mois), temps estimé nécessaire pour que le patient puisse tirer profit du traitement, en particulier temps nécessaire à la mise en place de stratégies de soins ou de prise en charge sociale, d'insertion, etc.

Spanish

Save record 28

Record 29 2006-10-16

English

Subject field(s)
  • Cheese and Dairy Products
  • Hygiene and Health
CONT

The Food and Drug Administration(FDA) is advising that some soft cheeses made with raw milk present a health risk, especially to high risk groups, such as pregnant women, newborns, older adults, and people with weakened immune systems. Such raw milk soft cheeses can cause several serious infectious diseases including listeriosis, brucellosis, salmonellosis and tuberculosis.

French

Domaine(s)
  • Laiterie, beurrerie et fromagerie
  • Hygiène et santé

Spanish

Save record 29

Record 30 2006-08-18

English

Subject field(s)
  • Hygiene and Health
  • Food Additives
  • Regulations and Standards (Food)
CONT

The first has to do with our proposed rule on food and color additives. This was something that was issued back in December of 1995. It also has enormous significance in the sense that once FDA [Food and Drug Administration] approves a food additive, our policy at the moment is that we also have to go through the process of adding that additive in our food additive table.

French

Domaine(s)
  • Hygiène et santé
  • Additifs alimentaires
  • Réglementation et normalisation (Alimentation)

Spanish

Save record 30

Record 31 2006-05-23

English

Subject field(s)
  • Medical and Surgical Equipment
DEF

[A system of postmarket monitoring] to ensure the safety of medical devices such as pacemakers, wheelchairs, stents, and other medical technologies.

CONT

Medical Device Surveillance : The medical device reporting regulation(1989/1990) requires the manufacturer to report device-related adverse events to the FDA [Food and Drug Administration] and the user facilities to report device-related injuries to the manufacturer and device related deaths to the FDA and the manufacturer.

OBS

medical device vigilance : term often used in official documents in Europe. Most of these documents refer to a key document (MEDDEV 2,12-1 rev4), in which the term "Medical Devices Vigilance" is used. In this construction, the plural use of "Device" is not idiomatic, and should be avoided.

OBS

medical device reporting : term used mostly in the United States of America. Under Medical Device Reporting, "Medical Device Reports" are sent to the FDA [Food and Drug Administration].

Key term(s)
  • medical devices vigilance

French

Domaine(s)
  • Équipement médico-chirurgical
DEF

[...] surveillance des incidents ou des risques d'incidents résultant de l'utilisation des dispositifs médicaux [...] après leur mise sur le marché [...]

CONT

Ensemble très hétérogène, les dispositifs médicaux (DM) sont soumis à une réglementation fondée sur trois concepts: - le marquage CE [Communauté Européenne], [...] - l'évaluation du service rendu [...] - et enfin la matériovigilance, organisée également au niveau national, qui permet la détection des failles de conception ou de fabrication et celle des anomalies de fonctionnement ou de vieillissement.

CONT

La matériovigilance comporte : le signalement et l'enregistrement des incidents ou des risques d'incidents [...]; l'enregistrement, l'évaluation et l'exploitation de ces informations dans un but de prévention; la réalisation de toutes études ou travaux concernant la sécurité d'utilisation des dispositifs médicaux; la réalisation et le suivi des actions correctives décidées.

Key term(s)
  • matério-vigilance

Spanish

Save record 31

Record 32 2006-04-11

English

Subject field(s)
  • Immunology
CONT

Adjuvanted Influenza Vaccine Researchers for Vaxine have shown significant improvement(40 to 100 times) in the level of antibodies generated in mice from an influenza virus vaccine by the incorporation of the Advax adjuvant in the vaccine. Most current influenza vaccines do not include an adjuvant as the only FDA [Food and Drug Administration] approved adjuvant Alum is ineffective in this type of vaccine.

OBS

Adjuvant: an additive (eg, alum) incorporated into or injected simultaneously with a vaccine to potentiate (increase) the immune system response.

French

Domaine(s)
  • Immunologie
CONT

Considérant d'une part : [...] que, d'après la méta-analyse présentée par le fabricant, le vaccin antigrippal avec adjuvant au squalène confèrerait un taux élevé de séroprotection, supérieur à celui du comparateur, chez les sujets âgés de 65 ans et plus et aurait un effet protecteur supérieur aux vaccins antigrippaux sans adjuvant dans cette population, notamment chez les sujets âgés présentant une pathologie associée (diabète, maladie cardiaque ou respiratoire chronique) [...].

OBS

Adjuvant : une substance qui, administrée avant ou en même temps qu'un antigène, modifie et généralement augmente la réponse immunologique de l'hôte.

Spanish

Save record 32

Record 33 2005-06-21

English

Subject field(s)
  • Animal Feed (Agric.)
  • Animal Diseases
CONT

On June 5, 1997, the Food & Drug Administration(FDA) published a final rule prohibiting the use of mammalian protein(i. e. animal protein products such as meat and bone meal) in feeds for ruminant animals... The intent of the rule is to help ensure that bovine spongiform encephalopathy(BSE) or "mad cow disease" does not become established in the United States and spread through the feed supply to other animals.

French

Domaine(s)
  • Alimentation des animaux (Agric.)
  • Maladies des animaux

Spanish

Campo(s) temático(s)
  • Alimentación animal (Agricultura)
  • Enfermedades de los animales
Save record 33

Record 34 2005-01-26

English

Subject field(s)
  • Biochemistry
CONT

FDA [Food and Drug Administration] approves Palifermin, a modified version of a naturally occurring human protein called keratinocyte growth factor(KGF) that is manufactured in a laboratory.

French

Domaine(s)
  • Biochimie

Spanish

Save record 34

Record 35 2004-09-28

English

Subject field(s)
  • Medication
  • Pharmacodynamics
DEF

The designation for a new drug that is under study in the first clinical patients for its effects under carefully controlled conditions.

OBS

Approval for such studies is obtained from the Food and Drug Administration, Bureau of Drugs, after a review of earlier, preclinical, animal studies. Proof of efficacy and safety is required to advance to new drug status.

French

Domaine(s)
  • Médicaments
  • Pharmacodynamie
DEF

Nouvelle drogue dont l'emploi est autorisé par le gouvernement à des fins de recherche.

Key term(s)
  • nouvelle drogue de recherche

Spanish

Campo(s) temático(s)
  • Medicamentos
  • Farmacodinámica
Save record 35

Record 36 2004-05-10

English

Subject field(s)
  • Food Industries
CONT

All foods and beverages whether or not intended for human consumption are sujbect to the proposed requirements, according to the US Food and Drug Administration(FDA). The law also requires domestic and foreign food and drink-makers who produce food for human or animal consumption to register their plants with the FDA...

French

Domaine(s)
  • Industrie de l'alimentation
CONT

Les personnes qui voyagent à destination de pays étrangers sont peut-être les premières à vouloir diversifier leur alimentation, mais celles qui restent au pays sont de plus en plus intéressées à adopter des aliments étrangers.

Spanish

Save record 36

Record 37 2004-02-03

English

Subject field(s)
  • Food Additives
CONT

Food coloring agents may be organic or inorganic, natural or synthetic. Prominent among them are the(erroneously called) coal-tar colors certified for food use in the United States by the Food and Drug Administration. These and certain vegetable colors such as annatto, turmeric, and beta-carotene(now also produced synthetically) have wide usage in butter and margarine, mustard and other condiments, candies, ice cream, cake toppings, beverages, and other products. The greater variety, coloring value, and stability of synthetic, as compared to natural, colors favor their use in processed foods.

Key term(s)
  • food colouring agent

French

Domaine(s)
  • Additifs alimentaires
DEF

Produit chimique utilisé pour la fabrication de certaines denrées alimentaires.

CONT

L'addition de colorants à certains aliments est autorisée. Ce sont soit des constituants des plantes habituellement consommées tels que les chlorophylles (légumes verts), la bétaïne (betterave rouge), le carotène (carotte), les anthocyanes (raisin, cassis), soit des substances extraites d'animaux ou de végétaux ne participant pas à notre alimentation normale telles la cochenille et l'indigotine, ou encore des substances obtenues à partir de substances naturelles mais ayant subi une transformation (caramel), ou enfin des produits de synthèse.

Spanish

Campo(s) temático(s)
  • Aditivos alimentarios
DEF

Substancia empleada en la coloración de ciertos alimentos.

OBS

colorante: Término utilizado para los fines del Codex Alimentarius.

Save record 37

Record 38 2003-10-09

English

Subject field(s)
  • Food Additives
  • Dyes and Pigments (Industries)
DEF

[Burgundy red] food coloring ... used in soft drinks, ice cream, pistachio nuts, candy, baked goods, pet foods, sausage, breakfast cereals, and other foods.

OBS

FD & C Red No. 2: FD and C Colors is the designation for the Food, Drug and Cosmetic Colors in the United States.

OBS

Since 1975, it has been banned from food use in Sweden and the USA [Food and Drug Administration].

French

Domaine(s)
  • Additifs alimentaires
  • Teintures et pigments (Industries)
DEF

Colorant pourpre de synthèse, utilisé pour les conserves de fruits rouges (cerises, fraises). Employé aussi en fromagerie, charcuterie, confiserie.

Spanish

Campo(s) temático(s)
  • Aditivos alimentarios
  • Tinturas y pigmentos (Industrias)
DEF

Sal trisódica del ácido 1-(4-sulfo-1 naftilazo)-naftol-3, 6 disulfónico, que por su llamativo color rojo se utiliza como colorante alimentario.

Save record 38

Record 39 2002-06-07

English

Subject field(s)
  • Government Bodies and Committees (Non-Canadian)
  • Biotechnology
OBS

The Center for Biologics Evaluation and Research(CBER) regulates biological products. Current authority for this responsibility resides in Section 351 of the Public Health Service Act and in specific sections of the Food Drug and Cosmetic Act [USA Administration].

French

Domaine(s)
  • Organismes et comités gouvernementaux non canadiens
  • Biotechnologie

Spanish

Campo(s) temático(s)
  • Organismos y comités gubernamentales no canadienses
  • Biotecnología
Save record 39

Record 40 2000-08-29

English

Subject field(s)
  • Immunology
  • Epidemiology
CONT

In addition, FDA [Food and Drug Administration] is proposing to make consistent and uniform the "look back" policy now being followed by blood centers. Blood centers are required to retrieve and quarantine units from prior collections whenever a repeat donor has a reactive screening test for HIV.

French

Domaine(s)
  • Immunologie
  • Épidémiologie
CONT

Le programme de sécurité appliqué au plasma comprend des mesures telles que l'exclusion de donneurs n'ayant fait qu'un don, l'utilisation de donneurs qualifiés ayant fait des dons répétés et une mise en quarantaine de trois mois du plasma avant sa mise en circulation pour fractionnement.

Spanish

Save record 40

Record 41 1999-07-27

English

Subject field(s)
  • Food Industries
  • Food Additives
CONT

Kelcogel(TM) gellan gum receives general food approval from U. S. Food and Drug Administration.

OBS

Gellan gum is a food additive for gelling and texturizing food such as sauces, dessert gels, microwaveable foods, confections, low-fat spreads, bakery fillings, and jellies.

OBS

A gelling agent.

French

Domaine(s)
  • Industrie de l'alimentation
  • Additifs alimentaires
CONT

La gomme gellane est un polysaccharide biosynthétisé par Pseudomonas elodea. On étudie, chez les personnes adultes, les effets de sa consommation, pendant 23 jours, sur la composition des feces, les teneurs en lipides du sérum et les indices hématologiques du sang. (Base de données Pascal).

OBS

Terme formé par analogie avec gomme guar, gomme xanthane, gomme arabique, etc.

Spanish

Save record 41

Record 42 1999-06-04

English

Subject field(s)
  • The Eye
OBS

Abbott and coworkers report their US Food and Drug Administration phase III results with intrastromal corneal ring segments for the correction of mild myopia(-1. 00 D to-3. 50 D).

OBS

Source: Canadian Journal of Ophthalmology.

French

Domaine(s)
  • Oeil
OBS

Abbott et ses collaborateurs présentent les résultats d'une étude de phase III (US Food and Drug Administration) sur les segments d'anneau cornéen intrastromal utilisés pour la correction d'une myopie légère (entre -1,00 D et -3,50 D).

OBS

Source : Société canadienne d'ophtalmologie.

Spanish

Save record 42

Record 43 1999-05-27

English

Subject field(s)
  • Food Industries
  • Dyes and Pigments (Industries)
CONT

... discoveries that resulted in the development of aniline and the coal-tar dyes led eventually to many of the synthetic colors now added to food.

CONT

Prominent among [food coloring agents] are the... coal-tar colors certified for food use in the United States by the Food and Drug Administration. These and certain vegetable colors... have wide usage in butter and margarine, mustard and other condiments, candies... The greater variety, coloring value, and stability of synthetic, as compared to natural, colors favor their use in processed foods.

OBS

Although, technically, there is a distinction between the terms "dye" and "colour", according to Dr. Conacher, Food Research Division, Health and Welfare, they are used synonymously in literature about food additives.

French

Domaine(s)
  • Industrie de l'alimentation
  • Teintures et pigments (Industries)
CONT

En 1856 [...] William Perkin, observa en effet qu'en oxydant l'aniline impure [...] il se formait un colorant mauve [...] Stimulés par ce succès, d'autres chimistes soumirent l'aniline à l'action de divers oxydants, ou d'autres réactifs, et bientôt apparurent d'autres «colorants d'aniline». [...] Très vite, empiriquement, se développa une industrie qui utilisait comme matière première le goudron de houille : d'où les noms de colorants du goudron de houille ou de colorants d'aniline, quoique le goudron ne renferme aucun colorant.

Spanish

Save record 43

Record 44 1999-04-29

English

Subject field(s)
  • Food Additives
  • Fatty Substances (Food)
DEF

An oil (mainly of vegetable origin) that contains a certain amount of brome. Used in soft drinks, cream and some bakery products.

OBS

The Food and Drug Administration have the brominated vegetable oils on the "suspect list".

French

Domaine(s)
  • Additifs alimentaires
  • Corps gras (Ind. de l'aliment.)
DEF

Huile, surtout végétale, traitée au brome. Utilisée dans les boissons gazeuses, les crèmes et certains produits boulangers.

Spanish

Save record 44

Record 45 1997-11-06

English

Subject field(s)
  • Cytology
CONT

The Food and Drug Administration has approved an enzyme immunoassay for the in vitro quantitative determination of nuclear matrix protein NMP22 in stabilized voided urine, the Matritech NMP22R Test Kit(Matritech Inc.). The test kit is indicated as an aid in the management of patients with transition cell carcinoma of the urinary tract, after surgical treatment to identify those patients with occult or rapidly recurring cancer.

French

Domaine(s)
  • Cytologie
CONT

Parmi les affections malignes du système urinaire, le cancer de la vessie ou carcinome des cellules de transition (TCC) est le plus répandu. Pour les seuls États-Unis, par exemple, il touche 51 000 personnes.

Spanish

Save record 45

Record 46 1997-01-20

English

Subject field(s)
  • Genetics
  • Biotechnology
CONT

The potential therapeutic applications of encapsulated cell technology are enormous... It appears likely that over the end of the decade clinical trials of encapsulated cells to treat many diseases will become a reality. The Food and Drug Administration has already authorized studies to evaluate the safety and biological activity of several types of systems. A number of issues will have to be addressed, including the sourcing of raw materials, the design and building of manufacturing facilities, the scale-up and optimization process, storage and distribution of the product, and quality control.

French

Domaine(s)
  • Génétique
  • Biotechnologie

Spanish

Save record 46

Record 47 1996-06-18

English

Subject field(s)
  • Government Bodies and Committees (Non-Canadian)
OBS

part of the Food and Drug Administration

French

Domaine(s)
  • Organismes et comités gouvernementaux non canadiens

Spanish

Save record 47

Record 48 1996-06-18

English

Subject field(s)
  • Government Bodies and Committees (Non-Canadian)
OBS

part of the Food and Drug Administration

French

Domaine(s)
  • Organismes et comités gouvernementaux non canadiens

Spanish

Save record 48

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