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Food and Drug Administration (FDA) Federal Food Drug and Cosmetic Act (FFDCA) Center for Drug Evaluation and Research (CDER)

Rivkin Radler LLP

The Case of ‘Gas Station Heroin’

Rivkin Radler LLP on

Is It Necessary for Congress to Amend the FD&C Act for FDA to Have the Authority to Prohibit Tianeptine’s Sale? If the answer to this question is “no,” why are bills being introduced into Congress to give the U.S. Food and...more

Alston & Bird

Health Care Week in Review: HHS Finalizes 340B ADR Rule; House and Senate Hold Hearings on President’s FY 2025 HHS Budget

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Mintz - Health Care Viewpoints

FDA Faces Critical Deadlines in 2024, Even Without an Election Looming

The American public knows that 2024 is a critical election year, with the next race for the presidency in November expected to be another face-off between President Biden and former President Trump. What the majority may not...more

MoFo Life Sciences

FDORA Passage Brings Significant Changes To FDA’S Drug, Device, And Cosmetic Authorities

MoFo Life Sciences on

The Consolidated Appropriations Act for 2023 was signed into law on December 29, 2022 and includes the Food and Drug Omnibus Reform Act (FDORA). FDORA authorizes a variety of new and important amendments to the Food, Drug,...more

King & Spalding

Act II: The Senate Unveils Its Draft

King & Spalding on

On May 27, 2022, Senate Health, Education, Labor, and Pensions (“HELP”) Committee leaders introduced the Food and Drug Administration Safety and Landmark Advancements Act of 2022 (“FDASLA Act of 2022”), which, if passed,...more

Akin Gump Strauss Hauer & Feld LLP

New FDA Guidance Clarifies Exemptions for Digital Health Software

• Two new draft guidances aim to conform FDA’s existing digital health-related policies to the software exemptions from the device definition added by Cures, and are largely faithful to those legislative provisions. • The...more

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