RAC Regulatory Agency Interactions 3 — Questions and Answers
Question 1: What is the standard PDUFA review goal for a Priority Review NDA/BLA?
- 6 months from filing date (Correct answer)
- 10 months from filing date
- 12 months from receipt date
- 18 months from submission date
Correct answer: 6 months from filing date
Under PDUFA, Priority Review applications have a 6-month review goal from the filing date, compared to 10 months for Standard Review.
Question 2: During an FDA inspection, what does a Form FDA 483 represent?
- A warning letter indicating regulatory action will follow
- A notice of inspectional observations of conditions that may constitute violations (Correct answer)
- An official citation requiring immediate product recall
- A form confirming successful GMP compliance
Correct answer: A notice of inspectional observations of conditions that may constitute violations
Form FDA 483 lists inspectional observations of conditions that the investigator believes may constitute violations, giving the company an opportunity to respond before further action.
Question 3: What is the purpose of the EMA's Scientific Advice procedure?
- To provide binding regulatory decisions before marketing authorization
- To offer non-binding guidance on study design, data requirements, and development strategies (Correct answer)
- To replace the formal marketing authorization application
- To audit GMP compliance at manufacturing facilities
Correct answer: To offer non-binding guidance on study design, data requirements, and development strategies
EMA Scientific Advice provides non-binding guidance to developers on methodological, scientific, and regulatory questions during product development.
Question 4: Under the FDA's refuse-to-file (RTF) policy, within how many days of submission can FDA refuse to file an NDA?
- 15 days
- 30 days
- 60 days (Correct answer)
- 90 days
Correct answer: 60 days
FDA has 60 days from NDA receipt to conduct a filing review and issue a refuse-to-file action if the application is incomplete on its face.
Question 5: Which communication tool do regulatory agencies use to send formal questions to applicants during the review of a marketing authorization application?
- A Warning Letter
- A List of Questions (LoQ) or Information Request (Correct answer)
- A Complete Response Letter
- A Citizen Petition
Correct answer: A List of Questions (LoQ) or Information Request
During review, agencies such as EMA issue a List of Questions (LoQ) and FDA issues Information Requests or discipline review letters to seek clarification from applicants.
Question 6: What is the significance of a Special Protocol Assessment (SPA) agreement with FDA?
- It guarantees product approval if trial endpoints are met
- It confirms FDA's agreement that trial design, endpoints, and analyses adequately address development objectives (Correct answer)
- It exempts a sponsor from post-market commitments
- It allows marketing before Phase 3 data are complete
Correct answer: It confirms FDA's agreement that trial design, endpoints, and analyses adequately address development objectives
An SPA provides FDA agreement that the clinical trial design, endpoints, and statistical analyses are adequate to support a regulatory submission; it does not guarantee approval.
Question 7: When a company receives a Warning Letter from FDA, what is the typical expected response timeframe?
- 7 days
- 15 days
- 30 days (Correct answer)
- 60 days
Correct answer: 30 days
FDA Warning Letters typically request a written response within 15 working days (approximately 3 calendar weeks), though 30 calendar days is the common standard timeframe cited.
RAC Regulatory Agency Interactions 3
What is the standard PDUFA review goal for a Priority Review NDA/BLA?