Product Development & Registration 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 Product Development & Registration flashcards as text
A biologics manufacturer files a Biologics License Application (BLA). Under which regulatory authority is a BLA reviewed, as distinct from an NDA?
Answer: Section 351 of the Public Health Service (PHS) Act
BLAs for biological products are regulated under Section 351 of the Public Health Service Act, while NDAs are regulated under Section 505 of the FD&C Act.
What is the concept of 'rolling review' as it applies to FDA's expedited programs?
Answer: FDA reviews each module of the NDA as it is completed, rather than waiting for the entire submission
Rolling review allows sponsors with Fast Track or Breakthrough Therapy designation to submit completed NDA sections for review before the full application is filed.
Under 21 CFR 314.50, what is required to be included in the 'Summary' section (Module 2) of an NDA?
Answer: Comprehensive summaries of quality, nonclinical, and clinical data including an integrated benefit-risk assessment
Module 2 of the CTD/NDA requires structured summaries of quality, nonclinical, and clinical data, culminating in an integrated benefit-risk discussion.
Which of the following best describes a 'Type C' meeting with FDA during drug development?
Answer: A meeting to discuss special topics such as carcinogenicity protocols, pediatric study designs, or issues arising during review
Type C meetings cover any topic not included in Type A or B categories, such as carcinogenicity protocols, pediatric programs, or specific development questions.
What is the Hatch-Waxman Act's primary contribution to generic drug development in the US?
Answer: It established the ANDA pathway allowing generics to rely on the innovator's safety and efficacy data while demonstrating bioequivalence
The Hatch-Waxman Act (1984) created the abbreviated pathway (ANDA) that allows generic manufacturers to rely on the RLD's existing safety/efficacy data by demonstrating bioequivalence.
In a pediatric drug development program, what does a Pediatric Study Plan (PSP) require the sponsor to address?
Answer: The studies the sponsor plans to conduct in pediatric populations, relevant timelines, and justification for any waivers or deferrals
A PSP outlines the sponsor's plan for studying the drug in relevant pediatric populations, including study designs, age groups, and justification for any requested waivers or deferrals under PREA.
What is the purpose of a Documented Quality Management System (QMS) during pharmaceutical product development as described in ICH Q10?
Answer: To provide a framework of management responsibilities, processes, and resources that ensures product quality and continuous improvement throughout the product lifecycle
ICH Q10 describes the pharmaceutical QMS as a management system that integrates GMP requirements with continuous improvement principles across the entire product lifecycle.