RAC Regulatory Submissions and Approval 2

Question 1

Which FDA submission type is used to request approval for a generic drug product?

Accepted Answer

ANDA

Answer

An Abbreviated New Drug Application (ANDA) is the pathway for generic drug approval, referencing a previously approved Reference Listed Drug.

Question 2

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

Accepted Answer

To seek FDA feedback on planned submissions before they are filed

Answer

A Pre-Submission (Q-Sub) allows sponsors to obtain non-binding FDA feedback on regulatory strategies, study designs, or submission content before filing.

Question 3

Under 21 CFR Part 314, what is the standard FDA review clock for a standard NDA?

Accepted Answer

10 months

Answer

FDA's standard review goal for a standard NDA is 10 months from the date of filing.

Question 4

Which section of a Common Technical Document (CTD) contains the clinical study reports?

Accepted Answer

Module 5

Answer

Module 5 of the CTD contains clinical study reports, including results of clinical pharmacology, efficacy, and safety studies.

Question 5

A sponsor submits a Type II variation to the EMA. What does this typically involve?

Accepted Answer

A major change that may significantly affect the benefit-risk profile

Answer

A Type II variation involves a major change to a Marketing Authorization that may have a significant impact on the quality, safety, or efficacy of the product.

(RAC) Regulatory Affairs Certification Practice Test

(RAC) Regulatory Affairs Certification Practice Test

RAC Regulatory Submissions and Approval 2