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FDA and NIH Announce Initiatives to Reduce Animal Testing and Encourage Alternative Methodologies

The initiatives reflect the latest measures from federal agencies to reduce and ultimately replace animal testing in drug development and biomedical research....more

FDA Omnibus Reform Act: Examining the Policy Changes

The Act introduces key reforms to the FDA regulatory framework relating to drugs, biological products, and cosmetics, among others. On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023...more

Health Care & Life Sciences: Drug Pricing Digest - October 2022

Drug Pricing Reform: President Biden, in remarks delivered on Sept. 27, 2022, touted insulin pricing provisions in H.R. 5376, the Inflation Reduction Act of 2022 (IRA), which became law on Aug. 16, 2022. He referred to...more

Continuing Appropriations Act Includes FDA Reauthorization of User Fees

The Act reauthorizes FDA’s user fee programs but omits several proposed reforms to the FDA regulatory framework, setting the stage for further negotiations in Congress. Key Points: ..Congress authorized FDA to...more

FDA Announces Planned Changes to the 510(k) Premarket Notification Program

Agency signals forthcoming changes that could impact manufacturers’ ability to commercialize new medical devices. Background - On November 26, 2018, officials from the Food and Drug Administration (FDA or the Agency)...more

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