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
Under 21 CFR Part 312, what is the primary purpose of an Investigational New Drug (IND) application?
Answer: To authorize shipment of an unapproved drug for clinical investigation
An IND authorizes the interstate shipment and use of an unapproved drug or biological product in clinical investigations.
Which ICH guideline specifically addresses the stability testing of new drug substances and products?
Answer: ICH Q1A(R2)
ICH Q1A(R2) provides guidance on stability testing conditions, protocols, and data interpretation for new drug substances and products.
A sponsor submits a 505(b)(2) NDA. What distinguishes this pathway from a standard 505(b)(1) application?
Answer: It relies at least in part on data not developed by the applicant, such as published literature or FDA's findings for a previously approved drug
A 505(b)(2) NDA allows applicants to rely on data they did not develop, including FDA's prior findings of safety and effectiveness for a referenced drug.
During the IND review period, what is the standard FDA review clock before a clinical trial may begin (absent a clinical hold)?
Answer: 30 calendar days
FDA has 30 calendar days to review an IND; if no clinical hold is issued, the sponsor may proceed with the proposed investigation.
Which section of an NDA contains the proposed labeling, including prescribing information?
Answer: Module 1 — Administrative Information
Module 1 of the CTD/NDA contains administrative and regional documents including proposed labeling and prescribing information.
What is the significance of a Breakthrough Therapy designation granted by FDA?
Answer: It provides more intensive FDA guidance and organizational commitment to expedite development of a drug for serious conditions
Breakthrough Therapy designation provides intensive FDA guidance, senior agency involvement, and rolling review to expedite development of drugs addressing serious unmet needs.
In the context of a Pre-NDA meeting (Type B meeting), what is the primary goal of the sponsor?
Answer: To align with FDA on the completeness of the NDA package and any outstanding issues before submission
A Pre-NDA meeting allows sponsors to discuss the planned content and format of their submission to ensure FDA will accept it as a complete application.