Which act was implemented to speed up the approval of generic drugs?

Study for the Tennessee Multistate Pharmacy Jurisprudence Examination (MPJE). Utilize flashcards and multiple choice questions, each including hints and explanations. Prepare thoroughly for your exam!

The Waxman-Hatch Act, formally known as the Drug Price Competition and Patent Term Restoration Act of 1984, was designed specifically to facilitate the introduction of generic drugs to the market. One of its key components was the establishment of an abbreviated new drug application (ANDA) process, which allows generic drug manufacturers to demonstrate that their products are bioequivalent to brand-name drugs without having to conduct extensive clinical trials that are usually required for new drugs. This act balances the need for quicker access to more affordable generic medications while also considering the patent rights of brand-name drug manufacturers by extending patent terms in certain circumstances.

The other legislation mentioned, such as the Prescription Drug Marketing Act, primarily addresses drug marketing and distribution practices; the Kefauver-Harris Act focuses on the efficacy and safety of drugs; while the DHA requirement does not have a well-defined presence in the context of accelerating generic drug approval. The specific aim of Waxman-Hatch to enhance the availability of generics makes it the correct answer in this context.

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