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FDA to Address Proposed Rule to Subject Laboratory Developed Tests to Agency Oversight in Public Webinar

FDA will hold a webinar regarding the proposed rule, which reiterates FDA’s assertion of jurisdiction over laboratory developed tests and proposes a phaseout of its general enforcement discretion approach. On October 31,...more

FDA Publishes Proposed Rule for Tobacco Product Manufacturing Practice Requirements

The proposed rule, if finalized, would impose new manufacturing practice requirements on foreign and domestic manufacturers of finished and bulk tobacco products. On March 10, 2023, the Food and Drug Administration (FDA...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

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

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

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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