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Federal Food Drug and Cosmetic Act (FFDCA) Regulatory Reform New Legislation

Hogan Lovells

HHS Secretary Directs FDA to Explore Rulemaking to Eliminate Self-GRAS Pathway

Hogan Lovells on

The Secretary of the U.S. Department of Health and Human Services (HHS), Robert F. Kennedy, Jr., recently issued a press release directing the Food and Drug Administration (FDA) to take steps to explore possible rulemaking to...more

Latham & Watkins LLP

Food and Drug Omnibus Reform Act Introduces Key Changes to FDA’s Authorities

Latham & Watkins LLP on

The legislation contains several reforms to FDA’s statutory authority and the regulatory framework that it administers. Key Points: ..Omnibus legislation appropriates new funds to FDA and reauthorizes certain FDA...more

Hogan Lovells

Biden signs bill limiting new drug exclusivity awards to innovations in active moiety

Hogan Lovells on

On April 23, U.S. President Biden signed into law two bills meant to lower prescription drug prices by limiting new drug exclusivity awards and promoting biosimilars. ...more

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