RAC Regulatory Submissions and Approval 3

Question 1

What does a 505(b)(2) NDA pathway allow a sponsor to do?

Accepted Answer

Rely in part on published literature or FDA's prior findings for a previously approved drug

Answer

The 505(b)(2) pathway allows sponsors to rely on published studies or FDA's prior approval findings, reducing the amount of new clinical data needed.

Question 2

Which ICH guideline specifically addresses the structure and content of clinical study reports for regulatory submissions?

Accepted Answer

ICH E3

Answer

ICH E3 provides guidance on the structure and content of clinical study reports submitted to regulatory authorities.

Question 3

Under FDA's 21 CFR 312.23, which of the following is NOT a required section of an IND application?

Accepted Answer

Post-marketing surveillance plan

Answer

A post-marketing surveillance plan is a post-approval requirement, not a component of an initial IND application.

Question 4

What is the significance of the 'refuse to file' (RTF) decision in NDA/BLA review?

Accepted Answer

FDA determines the application is not sufficiently complete to permit substantive review

Answer

An RTF decision means FDA found the application administratively or scientifically incomplete and will not begin the 10- or 6-month review clock.

Question 5

Which of the following best describes a Risk Evaluation and Mitigation Strategy (REMS)?

Accepted Answer

A program to ensure a drug's benefits outweigh its risks through specific safety measures

Answer

REMS are FDA-required programs for drugs with serious safety concerns that mandate specific interventions to ensure safe use.

(RAC) Regulatory Affairs Certification Practice Test