CRAP Regulatory Strategy & Submission Management 3 — Questions and Answers
Question 1: Under FDA regulations, which type of IND allows a marketed drug to be studied for a new indication without triggering full IND requirements for the initial phase?
- Commercial IND
- Exploratory IND (Phase 0 IND) (Correct answer)
- Emergency IND
- Treatment IND
Correct answer: Exploratory IND (Phase 0 IND)
An Exploratory IND (Phase 0) supports limited early human studies with subtherapeutic doses aimed at gaining pharmacokinetic or mechanistic data.
Question 2: When preparing a regulatory gap analysis for a product entering a new market, what is the FIRST step?
- Draft the submission dossier
- Identify the applicable regulatory requirements and compare them to the existing data package (Correct answer)
- Engage a local regulatory consultant to file the application
- Translate all existing documents into the target country's language
Correct answer: Identify the applicable regulatory requirements and compare them to the existing data package
A gap analysis begins by mapping existing data against target market requirements to identify missing studies, formats, or documentation.
Question 3: What is the maximum review period for a Standard Review NDA under PDUFA VII goals?
- 6 months
- 10 months (Correct answer)
- 12 months
- 18 months
Correct answer: 10 months
Under PDUFA VII, standard review NDAs have a 10-month review goal from the date of filing (60 days post-submission).
Question 4: A regulatory affairs team must decide whether to submit a Prior Approval Supplement (PAS) or a Changes Being Effected (CBE-30) supplement for a manufacturing change. Which factor determines this?
- The size of the manufacturing facility
- The potential risk of the change to product quality, safety, or efficacy (Correct answer)
- Whether the change affects the drug substance or drug product
- The cost of implementing the manufacturing change
Correct answer: The potential risk of the change to product quality, safety, or efficacy
The regulatory reporting category (PAS, CBE-30, CBE-0, or Annual Report) is determined by the risk level the change poses to product quality and patient safety.
Question 5: Which regulatory tool allows FDA to approve a drug based on a surrogate endpoint reasonably likely to predict clinical benefit, with post-marketing confirmation required?
- Standard approval
- Accelerated Approval (Correct answer)
- Breakthrough Therapy Designation
- Fast Track Designation
Correct answer: Accelerated Approval
Accelerated Approval (21 CFR Part 314 Subpart H) permits use of surrogate or intermediate endpoints with mandatory confirmatory post-marketing trials.
Question 6: In the ICH CTD structure, where is the Drug Substance section located?
- Module 2.3
- Module 3.2.S (Correct answer)
- Module 5.2
- Module 4.2.1
Correct answer: Module 3.2.S
Module 3.2.S contains the Drug Substance (active pharmaceutical ingredient) chemistry, manufacturing, and controls information in the CTD.
Question 7: A company receives an FDA Complete Response Letter (CRL). Within what timeframe must the company resubmit to be considered a Class 1 resubmission?
- Within 2 months
- Within 6 months
- No time limit applies for Class 1
- Within 3 months (Correct answer)
Correct answer: Within 3 months
A Class 1 resubmission addresses minor deficiencies and must be filed within 3 months of the CRL to qualify for a 2-month review goal.
CRAP Regulatory Strategy & Submission Management 3
Under FDA regulations, which type of IND allows a marketed drug to be studied for a new indication without triggering full IND requirements for the initial phase?