100+ Free RAC (Drugs) Practice Questions

Explanation: An IND must be in effect before a sponsor can lawfully ship an unapproved investigational drug interstate and administer it to humans in clinical trials. It is the mechanism that exempts the drug from the premarket approval requirements for the limited purpose of investigation. The NDA, ANDA, and BLA are all marketing applications submitted after clinical development.

Explanation: FDA has 30 calendar days from receipt of an original IND to review it. If FDA does not place the study on clinical hold within that period, the sponsor may begin the proposed clinical investigation. This 30-day default is codified in 21 CFR 312.40.

Explanation: Accelerated Approval permits approval based on a surrogate or intermediate clinical endpoint that is reasonably likely to predict clinical benefit, with the sponsor required to conduct confirmatory postmarketing trials to verify the benefit. If those trials fail to confirm benefit, FDA may withdraw approval. Fast Track and Breakthrough are designations that facilitate development, while Priority Review shortens the review clock.

Explanation: The Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman) created the 505(j) ANDA pathway, allowing generics to rely on FDA's prior finding of safety and effectiveness for the reference listed drug by demonstrating bioequivalence. The 505(b)(2) pathway was also enabled but is a hybrid NDA, not the generic pathway. The 351(k) biosimilar route came later under the BPCI Act of 2009.

Explanation: Biological products are licensed under Section 351 of the Public Health Service Act through a Biologics License Application (BLA). The NDA, by contrast, is used for small-molecule new drugs under the FD&C Act. Monoclonal antibodies, vaccines, and many therapeutic proteins are regulated as biologics requiring a BLA.

Explanation: Module 3 of the Common Technical Document contains the Quality (CMC) information, including drug substance and drug product manufacturing, controls, and stability. Module 1 holds regional administrative information, Module 2 contains overviews and summaries, Module 4 holds nonclinical study reports, and Module 5 holds clinical study reports.

Explanation: Under 21 CFR 312.32, a sponsor must notify FDA of a serious and unexpected suspected adverse reaction in a written IND safety report no later than 15 calendar days after determining the information qualifies. Unexpected fatal or life-threatening suspected adverse reactions require an even faster 7-calendar-day notification, which may be by telephone or fax/email.

Explanation: Under the Orphan Drug Act, approval of a designated orphan drug grants 7 years of marketing exclusivity for that indication, during which FDA generally may not approve another application for the same drug for the same rare disease or condition. This is distinct from the 5-year new chemical entity exclusivity and the 12-year reference product exclusivity for biologics.

Explanation: 21 CFR Parts 210 and 211 set out current Good Manufacturing Practice for finished pharmaceuticals, with Part 211 providing the detailed requirements for facilities, equipment, production, quality control, and records. Part 11 covers electronic records and signatures, Part 312 covers INDs, and Part 314 covers NDAs and ANDAs.

Explanation: The ICH Q series covers Quality topics, including stability (Q1), impurities (Q3), specifications (Q6), pharmaceutical development (Q8), quality risk management (Q9), and pharmaceutical quality systems (Q10). The E series covers Efficacy (clinical), the S series covers Safety (nonclinical), and the M series covers Multidisciplinary topics.