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
A company is conducting a benefit-risk analysis for a new drug submission. Which framework does FDA recommend for structured benefit-risk assessment?
Answer: FDA's Benefit-Risk Framework with five-factor analysis in Module 2.5
FDA's benefit-risk framework integrates analysis of disease severity, unmet need, benefits, risks, and risk management across the structured assessment in Module 2.5.
A regulatory strategy team identifies that their product may qualify for both Fast Track and Breakthrough Therapy designation. What is a key difference between these two designations?
Answer: Breakthrough Therapy includes intensive FDA guidance and organizational commitment; Fast Track offers rolling review and more frequent meetings
Breakthrough Therapy designation provides more intensive FDA involvement, senior leadership engagement, and cross-disciplinary guidance beyond what Fast Track offers.
In the eCTD submission lifecycle, what is the function of a 'sequence number' in each submission unit?
Answer: It uniquely identifies each individual submission in chronological order for a given application
Sequence numbers (e.g., 0000, 0001, 0002) are four-digit codes that chronologically identify each submission unit within an eCTD application lifecycle.
A sponsor wants to make a labeling change to add a new safety warning after post-marketing surveillance. Which supplement type is required?
Answer: CBE-0 (Changes Being Effected Immediately) supplement
Safety-related labeling changes to add or strengthen warnings can be implemented immediately via a CBE-0 supplement, which is submitted simultaneously with implementation.
What is the primary regulatory concern when submitting comparative effectiveness data in a 505(b)(2) NDA that references a listed drug?
Answer: The sponsor must address patent certifications (Paragraph I, II, III, or IV) for the reference listed drug
A 505(b)(2) applicant must certify with respect to each patent listed in the Orange Book for the reference drug, with Paragraph IV certifications triggering a 30-month stay.
During a regulatory submission review, which document type provides the overall scientific rationale and integrated summary of the clinical program within the CTD?
Answer: Module 2.5 Clinical Overview
Module 2.5 Clinical Overview provides the critical appraisal and integrated benefit-risk assessment of the entire clinical development program.
A company is submitting a global regulatory dossier and needs to address Japan's PMDA requirements. Which Japan-specific element is NOT part of the standard ICH CTD and must be added separately?
Answer: Japanese bridging study data and Module 1 Japan-specific administrative documents
Japan requires bridging studies to demonstrate that foreign clinical data is applicable to Japanese patients, plus Japan-specific Module 1 administrative documents not covered by the ICH CTD.