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NEW DRUG APPLICATION [4 records]
Record 1 - internal organization data 2018-02-26
Record 1, English
Record 1, Subject field(s)
- Official Documents
- Medication
- General Medicine, Hygiene and Health
Record 1, Main entry term, English
- new drug submission
1, record 1, English, new%20drug%20submission
correct, see observation, Canada, standardized
Record 1, Abbreviations, English
- NDS 2, record 1, English, NDS
correct, see observation, Canada
Record 1, Synonyms, English
- new drug application 3, record 1, English, new%20drug%20application
correct, see observation, United States, standardized
- NDA 4, record 1, English, NDA
correct, see observation, United States, standardized
- NDA 4, record 1, English, NDA
Record 1, Textual support, English
Record number: 1, Textual support number: 1 DEF
An application submitted by a manufacturer to [the competent authorities] for approval to market a new drug (a new, non-biological molecular entity) for human use. 3, record 1, English, - new%20drug%20submission
Record number: 1, Textual support number: 1 OBS
new drug submission; new drug application; NDA: terms, abbreviation and definition standardized by the Health Technology Assessment (HTA) Glossary English Editorial Board and the Translation Bureau. 5, record 1, English, - new%20drug%20submission
Record 1, French
Record 1, Domaine(s)
- Documents officiels
- Médicaments
- Médecine générale, hygiène et santé
Record 1, Main entry term, French
- présentation de nouveau médicament
1, record 1, French, pr%C3%A9sentation%20de%20nouveau%20m%C3%A9dicament
correct, feminine noun, standardized
Record 1, Abbreviations, French
- PNM 2, record 1, French, PNM
correct, feminine noun, standardized
Record 1, Synonyms, French
- dossier d'autorisation de mise sur le marché 1, record 1, French, dossier%20d%27autorisation%20de%20mise%20sur%20le%20march%C3%A9
correct, masculine noun, France, standardized
- dossier d'AMM 1, record 1, French, dossier%20d%27AMM
correct, masculine noun, France, standardized
- dossier de demande d'autorisation de mise sur le marché 1, record 1, French, dossier%20de%20demande%20d%27autorisation%20de%20mise%20sur%20le%20march%C3%A9
correct, masculine noun, France, standardized
- dossier de demande d'AMM 1, record 1, French, dossier%20de%20demande%20d%27AMM
correct, masculine noun, France, standardized
- présentation de drogue nouvelle 1, record 1, French, pr%C3%A9sentation%20de%20drogue%20nouvelle
see observation, feminine noun, Canada
- PDN 2, record 1, French, PDN
see observation, feminine noun, Canada
- PDN 2, record 1, French, PDN
Record 1, Textual support, French
Record number: 1, Textual support number: 1 DEF
Demande soumise par un fabricant [aux autorités compétentes] pour l'autorisation de commercialiser un nouveau médicament (une nouvelle entité moléculaire non biologique) pour usage chez l'humain. 1, record 1, French, - pr%C3%A9sentation%20de%20nouveau%20m%C3%A9dicament
Record number: 1, Textual support number: 1 OBS
Le terme «présentation de drogue nouvelle» (PDN) est à éviter, car «drogue» n'a pas le sens de «médicament» que le terme anglais «drug» peut avoir. En français, une drogue est soit une substance dont on fait un usage abusif à des fins non médicamenteuses, soit la matière première de certains médicaments. Toutefois, Santé Canada emploie «présentation de drogue nouvelle», et les fabricants peuvent être obligés de l'utiliser afin de se conformer aux exigences du Règlement sur les aliments et drogues. 1, record 1, French, - pr%C3%A9sentation%20de%20nouveau%20m%C3%A9dicament
Record number: 1, Textual support number: 2 OBS
présentation de nouveau médicament; PNM; dossier d'autorisation de mise sur le marché; dossier d'AMM; dossier de demande d'autorisation de mise sur le marché; dossier de demande d'AMM : termes et abréviation normalisés par l'Institut national d'excellence en santé et en services sociaux (INESSS) et le Bureau de la traduction. 3, record 1, French, - pr%C3%A9sentation%20de%20nouveau%20m%C3%A9dicament
Record 1, Spanish
Record 1, Textual support, Spanish
Record 2 - internal organization data 2014-01-24
Record 2, English
Record 2, Subject field(s)
- Scientific Research
- Official Documents
- Pharmacology
- General Medicine, Hygiene and Health
Record 2, Main entry term, English
- investigational new drug submission
1, record 2, English, investigational%20new%20drug%20submission
correct, see observation
Record 2, Abbreviations, English
- IND 2, record 2, English, IND
correct, see observation
Record 2, Synonyms, English
- IND submission 3, record 2, English, IND%20submission
correct, see observation
- investigational new drug application 4, record 2, English, investigational%20new%20drug%20application
correct, see observation, standardized
- IND 5, record 2, English, IND
correct, see observation, standardized
- IND 5, record 2, English, IND
- IND application 6, record 2, English, IND%20application
correct, see observation
Record 2, Textual support, English
Record number: 2, Textual support number: 1 DEF
An application for approval of an unapproved drug or a drug previously approved for another use, submitted by the manufacturer to [the competent authorities] prior to human testing of that drug. 4, record 2, English, - investigational%20new%20drug%20submission
Record number: 2, Textual support number: 1 OBS
The term new drug submission is used in Canada and the term new drug application is used in the United States. 4, record 2, English, - investigational%20new%20drug%20submission
Record number: 2, Textual support number: 2 OBS
investigational new drug application; IND: term and abbreviation standardized by the Health Technology Assessment (HTA) Glossary English Editorial Board and the Translation Bureau. 7, record 2, English, - investigational%20new%20drug%20submission
Record 2, French
Record 2, Domaine(s)
- Recherche scientifique
- Documents officiels
- Pharmacologie
- Médecine générale, hygiène et santé
Record 2, Main entry term, French
- présentation de nouveau médicament de recherche
1, record 2, French, pr%C3%A9sentation%20de%20nouveau%20m%C3%A9dicament%20de%20recherche
correct, feminine noun, standardized
Record 2, Abbreviations, French
- PNMR 2, record 2, French, PNMR
correct, feminine noun, standardized
Record 2, Synonyms, French
- demande d'autorisation de drogue nouvelle de recherche 1, record 2, French, demande%20d%27autorisation%20de%20drogue%20nouvelle%20de%20recherche
see observation, feminine noun, Canada
- DNR 2, record 2, French, DNR
see observation, feminine noun, Canada
- DNR 2, record 2, French, DNR
Record 2, Textual support, French
Record number: 2, Textual support number: 1 DEF
Demande d’autorisation d’un médicament non approuvé, ou approuvé préalablement pour un autre usage, soumise par le fabricant [aux autorités compétentes] avant l’expérimentation de ce médicament chez l’humain. 1, record 2, French, - pr%C3%A9sentation%20de%20nouveau%20m%C3%A9dicament%20de%20recherche
Record number: 2, Textual support number: 1 OBS
Le terme «demande d'autorisation de drogue nouvelle de recherche» (DNR) est à éviter, car «drogue» n’a pas le sens de «médicament» que le terme anglais «drug» peut avoir. En français, une drogue est soit une substance dont on fait un usage abusif à des fins non médicamenteuses, soit la matière première de certains médicaments. Toutefois, Santé Canada emploie «demande d'autorisation de drogue nouvelle de recherche», et les fabricants peuvent être obligés de l’utiliser afin de se conformer aux exigences du Règlement sur les aliments et drogues. 1, record 2, French, - pr%C3%A9sentation%20de%20nouveau%20m%C3%A9dicament%20de%20recherche
Record number: 2, Textual support number: 2 OBS
présentation de nouveau médicament de recherche; PNMR : terme et abréviation normalisés par l'Institut national d'excellence en santé et en services sociaux (INESSS) et le Bureau de la traduction. 3, record 2, French, - pr%C3%A9sentation%20de%20nouveau%20m%C3%A9dicament%20de%20recherche
Record 2, Spanish
Record 2, Textual support, Spanish
Record 3 - internal organization data 2002-05-06
Record 3, English
Record 3, Subject field(s)
- Veterinary Drugs
Record 3, Main entry term, English
- new animal drug application
1, record 3, English, new%20animal%20drug%20application
United States
Record 3, Abbreviations, English
Record 3, Synonyms, English
Record 3, Textual support, English
Record number: 3, Textual support number: 1 CONT
Transgenic animals in the United States are being regulated via pre-existing laws by "FDA" as "New animal drug applications." 1, record 3, English, - new%20animal%20drug%20application
Record 3, French
Record 3, Domaine(s)
- Médicaments vétérinaires
Record 3, Main entry term, French
- mise à l'essai d'un nouveau médicament pour les animaux
1, record 3, French, mise%20%C3%A0%20l%27essai%20d%27un%20nouveau%20m%C3%A9dicament%20pour%20les%20animaux
proposal, feminine noun, United States
Record 3, Abbreviations, French
Record 3, Synonyms, French
Record 3, Textual support, French
Record 3, Spanish
Record 3, Campo(s) temático(s)
- Medicamentos veterinarios
Record 3, Main entry term, Spanish
- aplicación de una nueva droga animal
1, record 3, Spanish, aplicaci%C3%B3n%20de%20una%20nueva%20droga%20animal
proposal, feminine noun, United States
Record 3, Abbreviations, Spanish
Record 3, Synonyms, Spanish
Record 3, Textual support, Spanish
Record 4 - internal organization data 1995-06-07
Record 4, English
Record 4, Subject field(s)
- Various Proper Names
- Medication
Record 4, Main entry term, English
- Abbreviated New Drug Application
1, record 4, English, Abbreviated%20New%20Drug%20Application
correct, United States
Record 4, Abbreviations, English
- ANDA 2, record 4, English, ANDA
correct, United States
Record 4, Synonyms, English
Record 4, French
Record 4, Domaine(s)
- Appellations diverses
- Médicaments
Record 4, Main entry term, French
- Abbreviated New Drug Application
1, record 4, French, Abbreviated%20New%20Drug%20Application
correct, United States
Record 4, Abbreviations, French
- ANDA 2, record 4, French, ANDA
correct, United States
Record 4, Synonyms, French
Record 4, Textual support, French
Record 4, Spanish
Record 4, Textual support, Spanish
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