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Food and Drug Administration (FDA) › Medicare Modernization Act › Federal Food Drug and Cosmetic Act (FFDCA)

Axinn, Veltrop & Harkrider LLP

Hatch-Waxman Overview

Axinn, Veltrop & Harkrider LLP on

The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, forms the current framework for the United States’ regulation of drug approvals. The law amended the Food, Drug, and...more

Axinn, Veltrop & Harkrider LLP

FDA After Chevron

Axinn, Veltrop & Harkrider LLP on

Under the Supreme Court's Chevron doctrine, courts will defer to a federal agency's interpretation of an ambiguous statute unless that interpretation is unreasonable. Chevron U.S.A. Inc. v. Natural Resources Defense Council,...more

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