FREE RAC Regulatory Submissions and Approval Questions and Answers

Question 1

A pharmaceutical company is preparing a marketing application for a new chemical entity to be submitted in the US, EU, and Japan.
Which document provides a harmonized structure for the quality, nonclinical, and clinical sections of the application, thereby streamlining the submission process across these regions?

Accepted Answer

Common Technical Document (CTD)

Answer

Investigational New Drug (IND) Application

Answer

Biologics License Application (BLA)

Answer

New Drug Application (NDA)

Question 2

A medical device company is preparing a premarket submission for a new Class II diagnostic device. The device has the same intended use and similar technological characteristics as a legally marketed device (a predicate device). Which type of submission is MOST appropriate to seek marketing authorization in the United States?

Accepted Answer

Premarket Notification (510(k))

Answer

Premarket Approval (PMA)

Answer

Investigational Device Exemption (IDE)

Answer

De Novo Classification Request

Question 3

A sponsor of an approved Class III medical device is required to submit post-approval reports to the FDA to ensure continued safety and effectiveness. Which of the following is a mandatory reporting requirement for the holder of an approved Premarket Approval (PMA) application?

Accepted Answer

Periodic Medical Device Reports (MDRs) for adverse events and annual reports.

Answer

Submitting a 510(k) for any manufacturing change.

Answer

Quarterly reports on sales and distribution data.

Answer

A De Novo petition to confirm the device classification.

Question 4

A pharmaceutical sponsor has an active Investigational New Drug (IND) application for a product in Phase 2 clinical trials. According to FDA regulations (21 CFR 312.33), what must the sponsor submit to the FDA within 60 days of the anniversary date of the IND going into effect?

Accepted Answer

An IND Annual Report

Answer

A New Drug Application (NDA)

Answer

A complete Development Safety Update Report (DSUR)

Answer

A 15-day Alert Report

Question 5

When preparing the technical documentation for a medical device to be marketed in the European Union under the Medical Device Regulation (MDR - EU 2017/745), which of the following is a critical component required in Annex II?

Accepted Answer

A detailed description of the design and manufacturing processes.

Answer

A copy of the company's annual financial report.

Answer

A summary of all marketing and sales activities.

Answer

The curriculum vitae of the company's Chief Executive Officer.

Question 6

A company receives approval for a New Drug Application (NDA). Several years post-approval, the FDA requires the sponsor to conduct a new clinical trial to assess a newly identified serious risk associated with the drug's long-term use. This type of study is BEST described as a:

Accepted Answer

Postmarket Requirement (PMR)

Answer

Phase 4 Clinical Trial

Answer

Investigator-Initiated Study

Answer

Post-Approval Commitment (PMC)