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- New_Drug_Application abstract "The New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the Food and Drug Administration (FDA) approve a new pharmaceutical for sale and marketing. The goals of the NDA are to provide enough information to permit FDA reviewers to establish the following: Is the drug safe and effective in its proposed use(s) when used as directed, and do the benefits of the drug outweigh the risks? Is the drug’s proposed labeling (package insert) appropriate, and what should it contain? Are the methods used in manufacturing (Good Manufacturing Practice, GMP) the drug and the controls used to maintain the drug’s quality adequate to preserve the drug’s identity, strength, quality, and purity?".
- New_Drug_Application wikiPageExternalLink DrugLag.html.
- New_Drug_Application wikiPageExternalLink book-excerpt-prescription-drug-product-submissions.aspx.
- New_Drug_Application wikiPageID "1340774".
- New_Drug_Application wikiPageRevisionID "596322460".
- New_Drug_Application hasPhotoCollection New_Drug_Application.
- New_Drug_Application subject Category:Clinical_research.
- New_Drug_Application subject Category:Drug_safety.
- New_Drug_Application subject Category:Food_and_Drug_Administration.
- New_Drug_Application subject Category:Pharmaceutical_industry.
- New_Drug_Application comment "The New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the Food and Drug Administration (FDA) approve a new pharmaceutical for sale and marketing.".
- New_Drug_Application label "New Drug Application".
- New_Drug_Application label "New Drug Application".
- New_Drug_Application sameAs New_Drug_Application.
- New_Drug_Application sameAs m.04v1mp.
- New_Drug_Application sameAs Q1368197.
- New_Drug_Application sameAs Q1368197.
- New_Drug_Application wasDerivedFrom New_Drug_Application?oldid=596322460.
- New_Drug_Application isPrimaryTopicOf New_Drug_Application.