RAC Regulatory Strategic Planning 2 — Questions and Answers
Question 1: When developing a regulatory strategy for a combination product in the US, which FDA center typically takes lead jurisdiction?
- The center with the most expertise in the primary mode of action (Correct answer)
- Always CDER regardless of device component
- Always CDRH regardless of drug component
- The center chosen by the sponsor
Correct answer: The center with the most expertise in the primary mode of action
FDA assigns lead jurisdiction to the center whose regulation is most appropriate based on the primary mode of action of the combination product.
Question 2: A company is planning global market entry for a Class II medical device. Which regulatory pathway typically offers the fastest US market access?
- PMA
- 510(k) with predicate (Correct answer)
- De Novo classification
- Humanitarian Device Exemption
Correct answer: 510(k) with predicate
A 510(k) submission demonstrating substantial equivalence to a legally marketed predicate device is the fastest pathway for Class II devices.
Question 3: In regulatory strategic planning, a 'critical path' analysis primarily helps identify:
- The most cost-effective regulatory consultants
- Activities that directly impact the overall project timeline (Correct answer)
- Which countries to enter first based on market size
- The optimal clinical study design
Correct answer: Activities that directly impact the overall project timeline
Critical path analysis identifies the sequence of dependent activities that determine the minimum time required to complete a project.
Question 4: Which of the following best describes a 'regulatory gap analysis' in strategic planning?
- Comparing competitor regulatory filings to identify opportunities
- Assessing current dossier status against requirements for target markets (Correct answer)
- Evaluating FDA inspection gaps in manufacturing sites
- Identifying missing clinical data in published literature
Correct answer: Assessing current dossier status against requirements for target markets
A regulatory gap analysis compares the existing data package against the submission requirements for target regulatory agencies to identify what additional work is needed.
Question 5: Under ICH E8(R1), which approach is emphasized for clinical trial design in regulatory strategy?
- Largest possible sample size to ensure statistical power
- Risk-based and fit-for-purpose design tailored to the specific question (Correct answer)
- Randomized controlled trials as the only acceptable design
- Adaptive designs requiring fewer patients
Correct answer: Risk-based and fit-for-purpose design tailored to the specific question
ICH E8(R1) emphasizes a risk-proportionate, fit-for-purpose approach to clinical study design that focuses on quality factors critical to the study's objectives.
Question 6: A regulatory affairs professional is assessing whether to use FDA's Breakthrough Therapy Designation (BTD). Which criterion is most critical?
- The drug must treat a rare disease with fewer than 200,000 US patients
- Preliminary clinical evidence shows substantial improvement over available therapy for serious conditions (Correct answer)
- The drug must have orphan designation already granted
- Phase 3 trials must already be completed
Correct answer: Preliminary clinical evidence shows substantial improvement over available therapy for serious conditions
BTD requires preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over existing therapies on a clinically significant endpoint for serious conditions.
Question 7: In the context of regulatory strategic planning, 'lifecycle management' refers to:
- Managing employee careers within the regulatory department
- Planning regulatory activities from development through post-market to maximize product value (Correct answer)
- The FDA's process for reviewing product changes over time
- Annual renewal of marketing authorizations
Correct answer: Planning regulatory activities from development through post-market to maximize product value
Regulatory lifecycle management encompasses all regulatory activities from initial development through post-approval changes, line extensions, and eventual product discontinuation.
RAC Regulatory Strategic Planning 2
When developing a regulatory strategy for a combination product in the US, which FDA center typically takes lead jurisdiction?