RAC Regulatory Agency Interactions 2 — Questions and Answers
Question 1: What is the primary purpose of a Pre-Submission (Q-Sub) meeting with FDA?
- To obtain binding approval before filing
- To get FDA feedback on planned submissions or study designs before they are submitted (Correct answer)
- To negotiate user fees for the application
- To request expedited review of a pending application
Correct 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.
Question 2: 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?
- 15 days
- 30 days (Correct answer)
- 45 days
- 60 days
Correct 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.
Question 3: Which FDA meeting type is categorized as 'Type B' for drug development?
- Meetings requested to discuss labeling post-approval
- End-of-Phase 2 meetings and pre-NDA/BLA meetings (Correct answer)
- Meetings to resolve manufacturing disputes
- Post-market surveillance planning meetings
Correct 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.
Question 4: What must a sponsor do if FDA issues a Complete Response Letter (CRL) for an NDA?
- Withdraw the application immediately
- Resubmit a new NDA from scratch
- Respond to all deficiencies identified or request a meeting to discuss them (Correct answer)
- Automatically receive approval after 6 months
Correct 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.
Question 5: Which program allows FDA to expedite the development and review of drugs for serious conditions where preliminary evidence shows substantial improvement over available therapies?
- Fast Track designation
- Breakthrough Therapy designation (Correct answer)
- Priority Review designation
- Accelerated Approval pathway
Correct 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.
Question 6: When interacting with the EMA, what is the role of a Rapporteur and Co-Rapporteur?
- They serve as legal representatives for the applicant
- They are CHMP members assigned to lead assessment of a marketing authorization application (Correct answer)
- They conduct GMP inspections at manufacturing sites
- They manage post-market surveillance programs
Correct 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.
Question 7: Which of the following best describes an FDA Advisory Committee meeting?
- A binding vote that FDA must follow to approve or reject a product
- A public meeting where independent experts provide non-binding recommendations to FDA (Correct answer)
- A closed hearing where only the applicant and FDA attend
- A mandatory step for all NDA/BLA submissions
Correct 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.
RAC Regulatory Agency Interactions 2
What is the primary purpose of a Pre-Submission (Q-Sub) meeting with FDA?