FDA Regulations Flashcards
7 cards from real CNPR practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 FDA Regulations flashcards as text
What is the significance of a drug receiving 'Priority Review' designation from the FDA?
Answer: FDA reviews the application within 6 months instead of the standard 10 months
Priority Review shortens the FDA's review goal from 10 months to 6 months for drugs that offer major advances in treatment or provide therapy where none existed.
Under the Federal Food, Drug, and Cosmetic Act, which entity has primary authority to regulate pharmaceutical promotion directed at healthcare professionals?
Answer: Food and Drug Administration (FDA)
The FDA's Office of Prescription Drug Promotion (OPDP) regulates all prescription drug promotion directed at healthcare professionals and consumers.
A pharmaceutical company wants to begin human clinical trials for a new investigational drug. What must they submit to the FDA first?
Answer: Investigational New Drug Application (IND)
An IND application must be submitted and allowed to proceed by the FDA before any human clinical trials can begin for an investigational drug.
Which FDA program provides expedited development and review for drugs intended to treat serious conditions where preliminary evidence shows the drug may demonstrate substantial improvement over available therapies?
Answer: Breakthrough Therapy designation
Breakthrough Therapy designation provides intensive FDA guidance and organizational commitment to expedite development of drugs showing early promise against serious conditions.
According to FDA regulations, pharmaceutical promotional materials must be submitted to the FDA using which form at the time of initial dissemination?
Answer: FDA Form 2253
FDA Form 2253 must be submitted at the time of initial dissemination or publication of promotional materials for prescription drugs.
The Durham-Humphrey Amendment of 1951 established what critical distinction in U.S. drug regulation?
Answer: The distinction between prescription-only and over-the-counter drugs
The Durham-Humphrey Amendment defined which drugs require a prescription and which can be sold over the counter, creating the modern Rx/OTC distinction.
Under FDA regulations governing pharmaceutical promotion, what does the term 'fair balance' require?
Answer: Risk information presented with similar prominence and depth as benefit information
Fair balance requires that promotional materials present risks and side effects with similar prominence, readability, and depth as the drug's benefits.