For public transparency, U.S. federal law (the FDA Amendments Act of 2007) requires clinical trial sponsors and investigators to register applicable clinical trials and then submit the study results ...

Published in the Federal Register, these amendments aim to enhance the performance of the review process for animal drugs and generic animal drugs. The Animal Drug User Fee Act (ADUFA), first ...

Citations: Dranove, David. 1991. The Costs of Compliance with the 1962 FDA Amendments--Editorial. Journal of Health Economics. (2)235-238.

The plaintiffs challenge the lawfulness under the Administrative Procedures Act of four separate actions by the FDA regarding mifepristone: the FDA’s initial approval in 2000; its amendments in ...

introducing amendments to the Food and Drug Regulations, CRC, c 870 and the Medical Devices Regulations, SOR/98-282, under the Food and Drugs Act, RSC 1985, c F-27. This proposal comes in response ...

In the next few years, the FDA found that several caused serious adverse effects and issued "The Color Additive Amendments of 1960" to the original act. About half of the original color additives ...

On January 16, 2025, the U.S. Food and Drug Administration (“FDA”) published a highly anticipated proposed rule on front-of-package (“FOP”) ...

If the EUA amendment is granted, Invivyd plans to initiate a clinical study in collaboration with the FDA to further assess pemivibart's virologic profile. PEMGARDA is currently authorized for ...

Companies that fail to follow Risk Evaluation and Mitigation Strategies (REMS) can face fines of up to $10 million, according to a new draft guidance released by the US Food and Drug ...