CNPR FDA Regulations 3

Question 1

What is the significance of a drug receiving 'Priority Review' designation from the FDA?

Accepted Answer

FDA reviews the application within 6 months instead of the standard 10 months

Answer

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?

Accepted Answer

Food and Drug Administration (FDA)

Answer

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?

Accepted Answer

Investigational New Drug Application (IND)

Answer

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?

Accepted Answer

Breakthrough Therapy designation

Answer

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?

Accepted Answer

FDA Form 2253

Answer

FDA Form 2253 must be submitted at the time of initial dissemination or publication of promotional materials for prescription drugs.

(CNPR) Certified National Pharmaceutical Representative Practice Test

(CNPR) Certified National Pharmaceutical Representative Practice Test

CNPR FDA Regulations 3