Regulatory Submissions and Approval 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 Submissions and Approval flashcards as text
What does a 505(b)(2) NDA pathway allow a sponsor to do?
Answer: Rely in part on published literature or FDA's prior findings for a previously approved drug
The 505(b)(2) pathway allows sponsors to rely on published studies or FDA's prior approval findings, reducing the amount of new clinical data needed.
Which ICH guideline specifically addresses the structure and content of clinical study reports for regulatory submissions?
Answer: ICH E3
ICH E3 provides guidance on the structure and content of clinical study reports submitted to regulatory authorities.
Under FDA's 21 CFR 312.23, which of the following is NOT a required section of an IND application?
Answer: Post-marketing surveillance plan
A post-marketing surveillance plan is a post-approval requirement, not a component of an initial IND application.
What is the significance of the 'refuse to file' (RTF) decision in NDA/BLA review?
Answer: FDA determines the application is not sufficiently complete to permit substantive review
An RTF decision means FDA found the application administratively or scientifically incomplete and will not begin the 10- or 6-month review clock.
Which of the following best describes a Risk Evaluation and Mitigation Strategy (REMS)?
Answer: A program to ensure a drug's benefits outweigh its risks through specific safety measures
REMS are FDA-required programs for drugs with serious safety concerns that mandate specific interventions to ensure safe use.
When must a sponsor submit a Safety Report (IND Safety Report) to the FDA during clinical trials?
Answer: Within 7 or 15 calendar days for serious unexpected suspected adverse reactions (SUSARs)
Fatal or life-threatening unexpected SUSARs must be reported within 7 calendar days; other serious unexpected SUSARs within 15 calendar days.
What is the purpose of a Pediatric Study Plan (PSP) under PREA in the US?
Answer: To agree with FDA on the studies needed to assess a drug's safety and efficacy in children
An agreed PSP under PREA (Pediatric Research Equity Act) establishes the pediatric studies required and the timeline for completion before or after approval.