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
6/14/2024
/ Abbreviated New Drug Application (ANDA) ,
Drug Pricing ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Hatch-Waxman ,
Life Sciences ,
Medicare Modernization Act ,
Orange Book ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
USPTO
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
3/7/2024
/ Abbreviated New Drug Application (ANDA) ,
Chevron Deference ,
Chevron v NRDC ,
Drug Design ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
International Trade Commission (ITC) ,
Medicare Modernization Act ,
Nutritional Supplements ,
Prescription Drugs ,
SCOTUS