RAC Regulatory Agency Interactions 2

Question 1

What is the primary purpose of a Pre-Submission (Q-Sub) meeting with FDA?

Accepted Answer

To get FDA feedback on planned submissions or study designs before they are submitted

Answer

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?

Accepted Answer

30 days

Answer

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?

Accepted Answer

End-of-Phase 2 meetings and pre-NDA/BLA meetings

Answer

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?

Accepted Answer

Respond to all deficiencies identified or request a meeting to discuss them

Answer

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?

Accepted Answer

Breakthrough Therapy designation

Answer

Breakthrough Therapy designation is intended to expedite development of drugs showing preliminary clinical evidence of substantial improvement over existing therapy for serious conditions.

(RAC) Regulatory Affairs Certification Practice Test

(RAC) Regulatory Affairs Certification Practice Test

RAC Regulatory Agency Interactions 2