Question 1
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?
Correct Answer:
Investigational New Drug application (IND)
Question 2
How many calendar days does FDA have to review an original IND submission before the sponsor may begin clinical trials, absent a clinical hold?
Correct Answer:
30 days
Question 3
Which FDA expedited program allows approval of a drug for a serious condition based on a surrogate endpoint reasonably likely to predict clinical benefit, with required confirmatory trials?
Correct Answer:
Accelerated Approval
Question 4
The Hatch-Waxman Amendments of 1984 established which abbreviated pathway for marketing generic versions of previously approved drugs?
Correct Answer:
505(j) Abbreviated New Drug Application
Question 5
Which marketing application is used to obtain US approval to market a biological product such as a monoclonal antibody or vaccine?
Correct Answer:
Biologics License Application (BLA)
Question 1
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About this Exam

Prepare with the RAC (Drugs) Practice Questions - Regulatory Affairs Certification - Drugs Exam practice quiz. This question bank includes 100 questions covering drug, clinical, application, sponsor, and information. Use it to review important concepts, identify knowledge gaps, and build confidence for the related exam, course, or assessment.

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

This practice set contains 100 questions from the matching question bank and focuses on drug, clinical, application, sponsor, and information. Work through each question carefully, review the provided solutions, and revisit topics that need more study before your next attempt.

This is an independent study resource intended for practice and review; it is not an official examination or an endorsement by any organization named in the title.

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