RAC Product Development & Registration 2 — Questions and Answers
Question 1: Under 21 CFR Part 312, what is the primary purpose of an Investigational New Drug (IND) application?
- To obtain final marketing approval from FDA
- To authorize shipment of an unapproved drug for clinical investigation (Correct answer)
- To request orphan drug designation for a rare disease product
- To notify FDA of a post-market safety issue
Correct 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.
Question 2: Which ICH guideline specifically addresses the stability testing of new drug substances and products?
- ICH Q8
- ICH Q9
- ICH Q1A(R2) (Correct answer)
- ICH Q10
Correct answer: ICH Q1A(R2)
ICH Q1A(R2) provides guidance on stability testing conditions, protocols, and data interpretation for new drug substances and products.
Question 3: A sponsor submits a 505(b)(2) NDA. What distinguishes this pathway from a standard 505(b)(1) application?
- It requires no clinical data whatsoever
- 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 (Correct answer)
- It is reserved exclusively for generic drug products
- It bypasses the advisory committee review process
Correct 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.
Question 4: During the IND review period, what is the standard FDA review clock before a clinical trial may begin (absent a clinical hold)?
- 7 calendar days
- 30 calendar days (Correct answer)
- 60 calendar days
- 90 calendar days
Correct 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.
Question 5: Which section of an NDA contains the proposed labeling, including prescribing information?
- Module 2 — Summaries
- Module 3 — Quality
- Module 1 — Administrative Information (Correct answer)
- Module 5 — Clinical Study Reports
Correct answer: Module 1 — Administrative Information
Module 1 of the CTD/NDA contains administrative and regional documents including proposed labeling and prescribing information.
Question 6: What is the significance of a Breakthrough Therapy designation granted by FDA?
- It automatically grants marketing approval without further review
- It provides more intensive FDA guidance and organizational commitment to expedite development of a drug for serious conditions (Correct answer)
- It waives all Phase 3 clinical trial requirements
- It grants the product seven years of market exclusivity
Correct 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.
Question 7: In the context of a Pre-NDA meeting (Type B meeting), what is the primary goal of the sponsor?
- To request accelerated approval based on surrogate endpoints
- To align with FDA on the completeness of the NDA package and any outstanding issues before submission (Correct answer)
- To negotiate post-market commitment requirements
- To obtain agreement on a Risk Evaluation and Mitigation Strategy (REMS)
Correct 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.
RAC Product Development & Registration 2
Under 21 CFR Part 312, what is the primary purpose of an Investigational New Drug (IND) application?