News & Analysis as of

Federal Food Drug and Cosmetic Act (FFDCA) Manufacturers New Regulations

Shook, Hardy & Bacon L.L.P.

FDA, HHS Announce Measures to Phase Out Petroleum-Based Dyes in Food

The U.S. Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) have announced actions to phase out petroleum-based synthetic dyes from foods in the U.S. food supply. In a news release, FDA said...more

Foley Hoag LLP

Congress Adds Some Teeth to FDA’s Authority to Regulate Cosmetics

Foley Hoag LLP on

The Food and Drug Administration (FDA) now has additional regulatory authorities over cosmetics, thanks to the Food and Drug Omnibus Reform Act (FDORA). FDORA was a part of the Consolidated Appropriations Act, 2023 (the...more

King & Spalding

Nearly a Century in the Making: Congress Modernizes FDA’s Regulation of Cosmetics

King & Spalding on

The Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”) was signed into law alongside other reforms to the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) on December 29, 2022, as part of a broader consolidated...more

Mintz - Health Care Viewpoints

Paradigm Shift: Regulating Software as a Medical Device in the U.S.

The U.S. Food and Drug Administration (FDA) is exploring the development of a new regulatory approach for software as a medical device (SaMD) that the agency believes will promote innovation while still assuring device safety...more

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