CRAP Regulatory Strategy & Submission Management 3

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?

Accepted Answer

Exploratory IND (Phase 0 IND)

Answer

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?

Accepted Answer

Identify the applicable regulatory requirements and compare them to the existing data package

Answer

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?

Accepted Answer

10 months

Answer

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?

Accepted Answer

The potential risk of the change to product quality, safety, or efficacy

Answer

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?

Accepted Answer

Accelerated Approval

Answer

Accelerated Approval (21 CFR Part 314 Subpart H) permits use of surrogate or intermediate endpoints with mandatory confirmatory post-marketing trials.

(CRAP) Certified Regulatory Affairs Professional Practice Test

(CRAP) Certified Regulatory Affairs Professional Practice Test

CRAP Regulatory Strategy & Submission Management 3