Tag: FDA generic approval

Federal Food, Drug, and Cosmetic Act: The Legal Backbone of Generic Drugs

Federal Food, Drug, and Cosmetic Act: The Legal Backbone of Generic Drugs

The Federal Food, Drug, and Cosmetic Act laid the groundwork for generic drugs through the Hatch-Waxman Amendments, enabling safe, affordable alternatives to brand-name medications while balancing innovation and competition.

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FDA Generic Approval Changes 2023-2025: What Manufacturers and Patients Need to Know

FDA Generic Approval Changes 2023-2025: What Manufacturers and Patients Need to Know

The FDA's 2023-2025 changes to generic drug approval are speeding up access to affordable medications by prioritizing U.S.-made generics. Here's what it means for patients, pharmacies, and manufacturers.

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