Regulatory Agency Interactions Flashcards
7 cards from real RAC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Regulatory Agency Interactions flashcards as text
What is the role of a regulatory affairs professional during an FDA Pre-Approval Inspection (PAI)?
Answer: To coordinate readiness, ensure documentation is accessible, and manage communication between FDA and manufacturing personnel
During a PAI, the RA professional helps coordinate site readiness, facilitates communication, ensures relevant records are accessible, and manages the inspection process professionally.
Under the EMA centralized procedure, what happens during the 'Day 120' step of the review?
Answer: The applicant receives the initial List of Questions and prepares responses
At Day 120, the applicant receives the consolidated List of Questions from CHMP and must prepare written responses to address all outstanding issues.
What is a Citizen Petition in the context of FDA interactions?
Answer: A formal request asking FDA to take or refrain from a specific regulatory action
A Citizen Petition allows any person to formally request that FDA take or refrain from a specific administrative action, such as requiring additional data before approving a competitor's product.
Which of the following best describes the 505(b)(2) regulatory pathway?
Answer: An application that relies at least partly on published literature or prior FDA findings for safety/efficacy
A 505(b)(2) NDA allows reliance on published literature or FDA's prior findings of safety and efficacy, reducing the data package required compared to a full 505(b)(1) NDA.
When preparing for a Type A FDA meeting, which of the following is true regarding the meeting timeline?
Answer: FDA targets scheduling within 30 days due to the urgent nature of Type A meetings
Type A meetings are reserved for critical situations (e.g., clinical holds, dispute resolutions) and FDA targets scheduling within 30 days of receiving the meeting request.
What is the primary purpose of a Regulatory Liaison function within a pharmaceutical company?
Answer: To serve as the main point of contact managing communication and relationships with regulatory agencies
The Regulatory Liaison function manages ongoing communication, meeting requests, and relationship management with regulatory agencies to ensure productive and consistent interactions.
In the US, which FDA Center is responsible for regulating combination products that primarily function as a biologic?
Answer: CBER
CBER (Center for Biologics Evaluation and Research) has primary jurisdiction over combination products that act primarily as a biologic, based on the primary mode of action determination.