What is another name for the Drug Price Competition and Patient Term Restoration Act of 1984?

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The Drug Price Competition and Patent Term Restoration Act of 1984 is widely recognized as the Hatch-Waxman Act. This legislation was pivotal in reshaping the drug approval process in the United States by facilitating the entry of generic drugs to the market while also extending patent terms for innovative drugs, thereby balancing the interests of brand-name pharmaceutical companies and generic manufacturers.

By allowing abbreviated New Drug Applications (ANDAs) for generics, the Hatch-Waxman Act helped reduce the time and cost associated with bringing these medications to market. This legislation is significant in encouraging competition and lowering drug prices for consumers, making it a foundational piece of pharmacy law.

The other options represent different pieces of legislation with their own specific focuses. For instance, the Food and Drug Modernization Act aimed to expedite the approval process for new drugs, while the Prescription Drug User Fee Act introduced fees for drug applications to fund the FDA. The Affordable Care Act primarily pertains to healthcare reform rather than specifically drug pricing or patent issues. Thus, the designation of the Drug Price Competition and Patent Term Restoration Act as the Hatch-Waxman Act is both accurate and important in understanding the landscape of pharmaceutical laws.

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