CNPR FDA Regulations 3 — Questions and Answers
Question 1: What is the significance of a drug receiving 'Priority Review' designation from the FDA?
- The drug is automatically approved without clinical trials
- FDA reviews the application within 6 months instead of the standard 10 months (Correct answer)
- The drug receives 10 years of market exclusivity
- The drug is exempt from post-marketing surveillance requirements
Correct 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.
Question 2: Under the Federal Food, Drug, and Cosmetic Act, which entity has primary authority to regulate pharmaceutical promotion directed at healthcare professionals?
- Drug Enforcement Administration (DEA)
- Federal Trade Commission (FTC)
- Food and Drug Administration (FDA) (Correct answer)
- Centers for Medicare & Medicaid Services (CMS)
Correct 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.
Question 3: A pharmaceutical company wants to begin human clinical trials for a new investigational drug. What must they submit to the FDA first?
- New Drug Application (NDA)
- Biologics License Application (BLA)
- Investigational New Drug Application (IND) (Correct answer)
- Abbreviated New Drug Application (ANDA)
Correct 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.
Question 4: 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?
- Fast Track designation
- Accelerated Approval
- Breakthrough Therapy designation (Correct answer)
- Priority Review designation
Correct 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.
Question 5: According to FDA regulations, pharmaceutical promotional materials must be submitted to the FDA using which form at the time of initial dissemination?
- FDA Form 483
- FDA Form 2253 (Correct answer)
- FDA Form 356h
- FDA Form 1571
Correct answer: FDA Form 2253
FDA Form 2253 must be submitted at the time of initial dissemination or publication of promotional materials for prescription drugs.
Question 6: The Durham-Humphrey Amendment of 1951 established what critical distinction in U.S. drug regulation?
- The difference between brand-name and generic drugs
- The distinction between prescription-only and over-the-counter drugs (Correct answer)
- The separation of drug manufacturing and distribution functions
- The difference between biological products and small-molecule drugs
Correct 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.
Question 7: Under FDA regulations governing pharmaceutical promotion, what does the term 'fair balance' require?
- Equal time given to competing drug products
- Risk information presented with similar prominence and depth as benefit information (Correct answer)
- Equal promotion spending across all indications
- Balanced representation of branded and generic options
Correct 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.
CNPR FDA Regulations 3
What is the significance of a drug receiving 'Priority Review' designation from the FDA?