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FDA Finalizes “Intended Use” Regulations

On August 2, 2021, the U.S. Food & Drug Administration (“FDA” or “the Agency”) published a final rule amending its medical product “intended use” regulations in an effort to provide direction and clarity to regulated industry...more

FDA Proposes New Rule Modifying its “Intended Use” Regulations

Yesterday, FDA published a proposed rule amending its medical product “intended use” regulations in an effort to “provide direction and clarity to regulated industry and other stakeholders.” If finalized, the rule would amend...more

USDA Publishes Long-Awaited Final Rule on the Labeling of “Bioengineered” Food

On December 21, 2018, the Agricultural Marketing Service (AMS) of the U.S. Department of Agriculture (USDA) issued a final rule1 (BE Final Rule) to implement the National Bioengineered Food Disclosure Standard (NBFDS),2 which...more

FDA Issues Draft Guidance Addressing Communications with Payors

On January 18, the Food and Drug Administration (FDA or the Agency) issued a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers. This...more

GMO Disclosures and Claims: A Possible End to the U.S. GMO Labeling Controversy?

On July 7, 2016, the U.S. Senate passed an important amendment to S. 764 to establish a mandatory nationwide labeling approach for genetically engineered (GE) foods, more popularly referred to as genetically modified...more

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