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
Under 21 CFR Part 11, which requirement applies to electronic records used to replace paper records in FDA-regulated industries?
Answer: Electronic signatures must be linked to their respective records
21 CFR Part 11 requires that electronic signatures be linked to their respective electronic records so that the signature cannot be excised, copied, or otherwise transferred to falsify records.
A drug manufacturer is transferring an approved manufacturing process to a new facility. What type of NDA supplement must typically be submitted?
Answer: Prior Approval Supplement
Manufacturing site changes that involve a new facility not already approved for the drug product typically require a Prior Approval Supplement (PAS) before implementation.
Which international regulatory body operates the Common Technical Document (CTD) format that is now required for drug applications in ICH member regions?
Answer: ICH
The International Council for Harmonisation (ICH) developed the CTD format, which harmonizes the structure of drug registration dossiers across the US, EU, Japan, and other member regions.
What is the primary difference between a Premarket Approval (PMA) and a 510(k) for medical devices?
Answer: PMAs require valid scientific evidence of safety and effectiveness; 510(k)s require substantial equivalence to a predicate
PMA is the most stringent pathway, requiring valid scientific evidence demonstrating reasonable assurance of safety and effectiveness, while 510(k) relies on demonstrating substantial equivalence to an already legally marketed device.
Under the Orphan Drug Act, what patient population threshold qualifies a disease for orphan designation in the United States?
Answer: Fewer than 200,000 patients
In the US, orphan drug designation applies to drugs intended to treat diseases or conditions affecting fewer than 200,000 people in the United States.
Which section of an IND application contains the proposed clinical protocol, investigator information, and human subject protection measures?
Answer: Section 6 - Protocols
Section 6 of the IND contains the protocols for proposed clinical investigations, including study design, patient selection criteria, and procedures for monitoring adverse events.
In the context of the EU Clinical Trials Regulation (EU CTR 536/2014), what is the primary platform used for submitting clinical trial applications?
Answer: CTIS (Clinical Trials Information System)
The Clinical Trials Information System (CTIS) is the single EU portal and database for submitting and managing clinical trial applications under EU CTR 536/2014.