RAC Regulatory Submissions and Approval 2 — Questions and Answers
Question 1: Which FDA submission type is used to request approval for a generic drug product?
- NDA
- ANDA (Correct answer)
- BLA
- IND
Correct answer: ANDA
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?
- To obtain binding approval for a product
- To seek FDA feedback on planned submissions before they are filed (Correct answer)
- To notify FDA of a manufacturing change
- To report an adverse event
Correct answer: To seek FDA feedback on planned submissions before they are filed
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?
- 6 months
- 10 months (Correct answer)
- 12 months
- 18 months
Correct answer: 10 months
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?
- Module 2
- Module 3
- Module 4
- Module 5 (Correct answer)
Correct answer: Module 5
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?
- A minor administrative change to the dossier
- A major change that may significantly affect the benefit-risk profile (Correct answer)
- A change of Marketing Authorization Holder name only
- An extension of the marketing authorization to a new indication
Correct answer: A major change that may significantly affect the benefit-risk profile
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.
Question 6: Which of the following best describes a Complete Response Letter (CRL) from the FDA?
- A letter granting full product approval
- A letter notifying the applicant of deficiencies that must be addressed before approval (Correct answer)
- A letter withdrawing a previously approved product
- A letter approving a product for accelerated use
Correct answer: A letter notifying the applicant of deficiencies that must be addressed before approval
A CRL informs the sponsor that FDA cannot approve the application in its current form and lists the deficiencies that must be resolved.
Question 7: In the EU, what is the Centralised Procedure (CP) most appropriate for?
- National products sold only in one member state
- Products containing new active substances or designated orphan medicines (Correct answer)
- Generic medicines referencing older products
- Products requiring only a Type IA variation
Correct answer: Products containing new active substances or designated orphan medicines
The Centralised Procedure is mandatory for certain product categories including new active substances, biotechnology products, and orphan medicines, granting a single EU-wide marketing authorization.
RAC Regulatory Submissions and Approval 2
Which FDA submission type is used to request approval for a generic drug product?