CRAP Regulatory Framework & Requirements 3

Question 1

Under the Hatch-Waxman Act, what is the maximum period of patent restoration that can be granted to a pharmaceutical patent holder?

Accepted Answer

5 years

Answer

The Hatch-Waxman Act allows restoration of up to 5 years of patent term lost during the regulatory review period, capped so total remaining term does not exceed 14 years post-approval.

Question 2

Which ICH guideline specifically addresses the stability testing of new drug substances and drug products?

Accepted Answer

ICH Q1A(R2)

Answer

ICH Q1A(R2) provides guidance on the stability testing requirements for new drug substances and new drug products intended for registration in ICH member countries.

Question 3

What is the purpose of a 510(k) substantial equivalence determination?

Accepted Answer

To demonstrate a device is as safe and effective as a legally marketed predicate device

Answer

Substantial equivalence means the new device has the same intended use and technological characteristics as the predicate, or any differences do not raise new safety/effectiveness questions.

Question 4

Under 21 CFR Part 312, which IND application type is used when a marketed drug is being studied for a new indication or new patient population?

Accepted Answer

Investigator IND

Answer

An Investigator IND is filed by an individual researcher (or sponsor) to study a drug for a new indication, new patient population, or new route of administration.

Question 5

Which regulatory concept describes the practice of using safety and efficacy data from one region to support approval in another region?

Accepted Answer

Bridging Study

Answer

A bridging study is conducted to allow extrapolation of foreign clinical data to a new region by demonstrating that the existing data are applicable to the new population.

(CRAP) Certified Regulatory Affairs Professional Practice Test

(CRAP) Certified Regulatory Affairs Professional Practice Test

CRAP Regulatory Framework & Requirements 3