CRAP Regulatory Framework & Requirements 3 — Questions and Answers
Question 1: Under the Hatch-Waxman Act, what is the maximum period of patent restoration that can be granted to a pharmaceutical patent holder?
- 3 years
- 5 years (Correct answer)
- 7 years
- 10 years
Correct answer: 5 years
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?
- ICH Q1A(R2) (Correct answer)
- ICH Q6A
- ICH Q8
- ICH E6
Correct answer: ICH Q1A(R2)
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?
- To prove a device is identical to a predicate
- To demonstrate a device is as safe and effective as a legally marketed predicate device (Correct answer)
- To waive clinical testing requirements
- To classify a device into Class I
Correct answer: To demonstrate a device is as safe and effective as a legally marketed predicate device
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?
- Investigator IND (Correct answer)
- Emergency IND
- Treatment IND
- Commercial IND
Correct answer: Investigator IND
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?
- Mutual Recognition
- Bridging Study (Correct answer)
- Extrapolation
- Abridged Application
Correct answer: Bridging Study
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.
Question 6: Under EU regulations, what does the CE marking on a medical device signify?
- The device was manufactured in the EU
- The device meets EU health, safety, and environmental requirements (Correct answer)
- The device has been clinically validated
- The device is approved by the EMA
Correct answer: The device meets EU health, safety, and environmental requirements
CE marking indicates that a product conforms to applicable EU legislation and meets essential safety and performance requirements, allowing free market access across the European Economic Area.
Question 7: Which FDA program provides expedited development and review for drugs treating serious or life-threatening conditions that demonstrate substantial improvement over available therapy?
- Fast Track
- Breakthrough Therapy (Correct answer)
- Accelerated Approval
- Priority Review
Correct answer: Breakthrough Therapy
Breakthrough Therapy Designation provides intensive FDA guidance for efficient drug development and is reserved for drugs showing preliminary clinical evidence of substantial improvement over existing therapies.
CRAP Regulatory Framework & Requirements 3
Under the Hatch-Waxman Act, what is the maximum period of patent restoration that can be granted to a pharmaceutical patent holder?