If a Generic Version of a Drug Is Approved for Marketing

question 4

Multiple Choice

If a generic version of a drug is approved for marketing on the basis of a study comparing the oral bioavailability of the generic and brand name product, which term is associated with the review of this product by the Food and Drug Administration?

• A) Harris-Kefauver amendment
• B) accelerated drug approval
• C) orphan drug amendment
• D) abbreviated new drug application
• E) investigational new drug

---

Definitions:

Ovary

A female reproductive organ in which oocytes (eggs) are produced, and hormones like estrogen and progesterone are secreted.

Prostate Gland

The prostate gland is a male reproductive organ that produces seminal fluid, which nourishes and transports sperm.

Uterine Horn

The uterine horn is a region where the uterus and the fallopian tubes meet; in some species, it significantly contributes to the site of fetal development.

Uterine Body

The central part of the uterus where implantation and development of the fetus occur.