Regulatory Agency Interactions Flashcards
7 cards from real RAC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Regulatory Agency Interactions flashcards as text
What is the primary purpose of a Pre-Submission (Q-Sub) meeting with FDA?
Answer: To get FDA feedback on planned submissions or study designs before they are submitted
A Pre-Submission meeting allows sponsors to obtain FDA feedback on their planned approaches before formal submission, reducing uncertainty and improving submission quality.
Under 21 CFR Part 312, what is the maximum number of days FDA has to place a proposed IND on clinical hold after receiving the application?
Answer: 30 days
FDA has 30 days to review a new IND and may place it on clinical hold within that period; if no hold is issued, the sponsor may proceed.
Which FDA meeting type is categorized as 'Type B' for drug development?
Answer: End-of-Phase 2 meetings and pre-NDA/BLA meetings
Type B meetings include End-of-Phase 2 (EOP2) and pre-NDA/BLA meetings, which are critical milestones in drug development requiring FDA input.
What must a sponsor do if FDA issues a Complete Response Letter (CRL) for an NDA?
Answer: Respond to all deficiencies identified or request a meeting to discuss them
A CRL informs sponsors of deficiencies; the sponsor must address all issues and resubmit or may request a meeting with FDA to discuss the deficiencies.
Which program allows FDA to expedite the development and review of drugs for serious conditions where preliminary evidence shows substantial improvement over available therapies?
Answer: Breakthrough Therapy designation
Breakthrough Therapy designation is intended to expedite development of drugs showing preliminary clinical evidence of substantial improvement over existing therapy for serious conditions.
When interacting with the EMA, what is the role of a Rapporteur and Co-Rapporteur?
Answer: They are CHMP members assigned to lead assessment of a marketing authorization application
The Rapporteur and Co-Rapporteur are CHMP members from EU member states assigned to perform the primary scientific assessment of a centralized marketing authorization application.
Which of the following best describes an FDA Advisory Committee meeting?
Answer: A public meeting where independent experts provide non-binding recommendations to FDA
Advisory Committee meetings bring together independent scientific experts to provide non-binding recommendations; FDA considers but is not required to follow the committee's vote.