Question

Which organization reviews new generic equivalents and therapeutic indications for existing medication?

a) FDA (Food and Drug Administration)
b) WHO (World Health Organization)
c) NABP (National Association of Boards of Pharmacy)
d) USP (United States Pharmacopeia)

Answer 1

The FDA (Food and Drug Administration) reviews new generic equivalents and therapeutic indications for existing medication.

Step-by-step explanation:

The organization that reviews new generic equivalents and therapeutic indications for existing medication is the FDA (Food and Drug Administration).

In order for a generic drug to be approved, the FDA requires scientific evidence that the generic drug is interchangeable with or therapeutically equivalent to the originally approved drug. This is done through the Abbreviated New Drug Application (ANDA) process.

For example, if a company wants to produce the generic equivalent of a brand-name medication, they must demonstrate to the FDA that their generic drug has the same active ingredients, strength, dosage form, and route of administration as the brand-name drug.