Ace the West Virginia MPJE 2025 – Pharmacist Pro Power-Up!

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Question: 1 / 400

Under the guidance of which law do generic drug manufacturers use the ANDA for approval?

Biologics Control Act of 1902

Generic drug manufacturers use the Abbreviated New Drug Application (ANDA) for approval under the guidance of the Hatch-Waxman Act (Price Competition and Patent Act) of 1984. This law created the ANDA pathway, which allows generic drug manufacturers to demonstrate bioequivalence to the reference listed drug without having to conduct extensive clinical trials. Therefore, the correct answer is C.

The other options are incorrect:

A. The Biologics Control Act of 1902 primarily focuses on regulating the production and sale of biological products.

B. The Drug Listing Act of 1972 is intended to provide the FDA with a list of all drugs being manufactured, prepared, propagated, compounded, or processed by a drug manufacturer.

D. The Prescription Drug Marketing Act of 1987 primarily addresses the distribution and wholesale marketing of prescription drugs to ensure their safety and effectiveness.

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Drug Listing Act of 1972

Hatch-Waxman Act (Price Competition and Patent Act) of 1984

Prescription Drug Marketing Act of 1987

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