CRAP Regulatory Strategy & Submission Management 2

Question 1

A company wants to market a drug in the EU and US simultaneously. Which regulatory strategy best supports parallel submissions?

Accepted Answer

Use ICH CTD format for both agencies and align clinical data packages

Answer

The ICH Common Technical Document (CTD) format is accepted by both FDA and EMA, enabling parallel submissions with a harmonized data package.

Question 2

Which FDA submission pathway is most appropriate for a drug with a condition of use in a small, well-defined rare disease population?

Accepted Answer

Orphan Drug designation with NDA or BLA

Answer

Orphan Drug designation is designed for conditions affecting fewer than 200,000 people in the US, providing incentives including market exclusivity.

Question 3

A regulatory submission has been placed on clinical hold by the FDA. What is the sponsor's primary next step?

Accepted Answer

Respond in writing to address all FDA concerns within the specified timeframe

Answer

The sponsor must submit a complete response addressing all clinical hold issues raised by FDA before clinical trials can resume.

Question 4

What is the primary purpose of a Pre-Submission (Q-Sub) meeting with FDA for a medical device?

Accepted Answer

To obtain FDA feedback on testing, study design, or submission requirements prior to formal filing

Answer

Pre-Submission meetings allow device sponsors to get FDA feedback on regulatory strategy, study design, and data requirements before filing.

Question 5

A company is developing a product that combines a drug with a diagnostic device. Under US regulations, how should the regulatory strategy be approached?

Accepted Answer

Develop a combination product strategy and determine the lead FDA center via RFD

Answer

A Request for Designation (RFD) is submitted to FDA's Office of Combination Products to determine the lead center and regulatory pathway for combination products.

(CRAP) Certified Regulatory Affairs Professional Practice Test

(CRAP) Certified Regulatory Affairs Professional Practice Test

CRAP Regulatory Strategy & Submission Management 2