RAC (Drugs) Practice Questions - Regulatory Affairs Certification - Drugs Exam

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Under the US Federal Food, Drug, and Cosmetic Act, which application must a sponsor submit to FDA before shipping an investigational new drug across state lines to begin clinical trials in humans?

New Drug Application (NDA) Abbreviated New Drug Application (ANDA) Investigational New Drug application (IND) Biologics License Application (BLA)

Correct Answer:

Investigational New Drug application (IND)

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