Regulatory Framework & Requirements Flashcards
7 cards from real CRAP 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 Framework & Requirements flashcards as text
Which US regulatory framework governs the safety and efficacy requirements for combination products that include both a drug and a device component?
Answer: 21 CFR Part 3 and the lead center determination process
21 CFR Part 3 establishes the process for determining which FDA center (CDER, CDRH, or CBER) has primary jurisdiction over combination products based on the primary mode of action.
Under the Regulatory Flexibility Act, what must federal agencies do when issuing regulations that may have a significant economic impact on small entities?
Answer: Conduct and publish a regulatory flexibility analysis
Agencies must prepare a regulatory flexibility analysis describing the rule's impact on small businesses and consider alternatives that minimize economic burden while achieving regulatory objectives.
A biologics manufacturer receives an FDA Form 483 during an inspection. What does this document represent?
Answer: Inspectional observations of potential violations noted by the investigator
FDA Form 483 lists inspectional observations where the investigator believes conditions or practices may violate CGMP regulations — it is not a final determination of violation.
Which concept in regulatory science refers to the use of surrogate endpoints that are 'reasonably likely to predict' clinical benefit, enabling Accelerated Approval?
Answer: Surrogate marker
Accelerated Approval under 21 CFR 601.41/314.510 allows approval based on a surrogate endpoint reasonably likely to predict clinical benefit, with required post-approval confirmatory trials.
Under the EU GDPR, which principle requires that personal data collected in clinical trials be adequate, relevant, and limited to what is necessary?
Answer: Data minimization
The data minimization principle under GDPR Article 5(1)(c) requires that personal data be limited to what is necessary in relation to the purposes for which it is processed.
Which ICH guideline establishes the common format for the Investigator's Brochure and specifies its required content sections?
Answer: ICH E6(R2)
ICH E6(R2), the Good Clinical Practice (GCP) guideline, specifies the content and format requirements for the Investigator's Brochure in Section 7.
A company is seeking FDA clearance for a novel in vitro diagnostic (IVD) device. Which regulatory pathway is most commonly used for moderate-risk IVDs with a predicate device?
Answer: 510(k) Premarket Notification
Most moderate-risk Class II IVD devices are cleared through the 510(k) pathway by demonstrating substantial equivalence to a legally marketed predicate device.