Regulatory Strategy & Submission Management Flashcards
7 cards from real CRAP 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 Strategy & Submission Management flashcards as text
Which ICH guideline specifically addresses the structure and content requirements for clinical study reports submitted in regulatory dossiers?
Answer: ICH E3
ICH E3 provides guidance on the structure and content of clinical study reports (CSRs) submitted to regulatory authorities.
A sponsor is developing a biologic and wants to rely on safety and efficacy data from an already-approved reference product. Which application pathway applies?
Answer: Biosimilar BLA under 351(k)
Section 351(k) of the PHS Act establishes the biosimilar pathway, allowing sponsors to rely on the reference product's safety and efficacy data.
What is the purpose of a Regulatory Agency Meeting Strategy document prepared before a Type B meeting with FDA?
Answer: To organize the sponsor's agenda, background document, and specific questions to maximize meeting outcomes
A meeting strategy document ensures the sponsor prepares clear questions, supporting data, and a background package to obtain actionable FDA feedback.
Under 21 CFR 314.81, post-marketing annual reports for approved NDAs must be submitted within how many months of the anniversary date of approval?
Answer: 2 months
NDA annual reports must be submitted within 60 days (approximately 2 months) of the anniversary date of approval per 21 CFR 314.81.
A company wants to obtain feedback on their planned Phase 3 protocol design for an NDA. Which FDA meeting type should they request?
Answer: Type B End-of-Phase 2 (EOP2) meeting
The End-of-Phase 2 (Type B) meeting is specifically designed for sponsors to discuss Phase 3 trial design and data requirements before initiating pivotal studies.
Which regulatory concept requires that all data supporting a submission be traceable, verifiable, and attributable to the original source?
Answer: Data Integrity (ALCOA principles)
ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate) principles define data integrity requirements across all regulatory submissions.
When is a 505(b)(2) NDA pathway most advantageous compared to a full 505(b)(1) NDA?
Answer: When the applicant can rely on existing published literature or FDA's finding of safety/efficacy for a previously approved drug
The 505(b)(2) pathway allows sponsors to reference FDA's prior finding of safety and efficacy, reducing the need for full clinical development programs.