Regulatory Frameworks 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 Frameworks flashcards as text
Under the Orphan Drug Act, a drug or biologic may receive orphan designation in the US if it treats a disease affecting fewer than how many people?
Answer: 200,000 people in the US
The Orphan Drug Act defines a rare disease as one affecting fewer than 200,000 persons in the United States, or where recovery of development costs is unlikely.
Health Canada's regulatory pathway for new drugs is governed by which regulation?
Answer: Food and Drug Regulations (C.08.002 to C.08.004)
New drug submissions in Canada are governed by the Food and Drug Regulations under Division 8, specifically sections C.08.002 through C.08.004.
What distinguishes a 505(b)(2) NDA from a traditional 505(b)(1) NDA?
Answer: 505(b)(2) relies at least partly on published literature or FDA's prior findings of safety/effectiveness for another approved drug
A 505(b)(2) NDA allows the sponsor to rely on published literature or FDA's prior findings for an already-approved drug, reducing the full data package needed.
According to ICH S9, nonclinical testing to support clinical development of anticancer pharmaceuticals is guided by what primary principle?
Answer: The benefit-risk balance for seriously ill patients permits flexibility in nonclinical study requirements
ICH S9 recognizes that for life-threatening diseases like cancer, a modified benefit-risk assessment justifies a flexible, staged approach to nonclinical safety testing.
Under EU GMP Annex 1 (Manufacture of Sterile Medicinal Products), Grade A cleanroom conditions are required for which operation?
Answer: Filling operations and making aseptic connections
Grade A (ISO 5) conditions, the highest EU GMP cleanroom classification, are required for filling operations, stopper bowls, open ampoules, and making aseptic connections.
A company discovers a safety signal in post-market surveillance for a marketed device. Under 21 CFR Part 803, a Malfunction Report must be submitted to FDA within:
Answer: 30 calendar days of becoming aware
Under 21 CFR Part 803.50, manufacturers must submit malfunction reports to FDA within 30 calendar days of becoming aware of a device malfunction.
The ASEAN Common Technical Dossier (ACTD) differs from the ICH CTD primarily in which section?
Answer: Module 1 is region-specific administrative information in both formats
Like the ICH CTD, ACTD Module 1 (Part I) contains region-specific administrative and prescribing information unique to ASEAN regulatory requirements.