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New Drug Application (NDA) - FDA
Jan 21, 2022 — The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing ...
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Investigational New Drug - Wikipedia
Investigational New Drug (IND) Application Process Center for Drug Evaluation and Research, Food and Drug Administration. ; ICH Guidance for Industry, E6 Good ...
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21 CFR § 314.50 - Content and format of an NDA.
An NDA for a new chemical entity will generally contain an application form, an index, a summary, five or six technical sections, case report tabulations of ...
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