Wisconsin MPJE (Pharmacy Jurisprudence) Test 2025 – 400 Free Practice Questions to Pass the Exam

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What was one of the key provisions of the Hatch-Waxman Amendment?

Approval process for biologics

One of the key provisions of the Hatch-Waxman Amendment was the establishment of an approval process for generic drugs. This amendment aimed to streamline the process for generic drug approval by allowing manufacturers to rely on the safety and efficacy data of the original brand-name drug, thereby promoting more affordable access to medication for patients. This provision helped pave the way for increased competition in the pharmaceutical market and contributed to cost savings for consumers.

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Established the concept of bioequivalence for generic drugs

Defined dietary supplements

Separated prescription from OTC drugs

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