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Life Sciences › Proposed Rules › Federal Food Drug and Cosmetic Act (FFDCA)

Quarles & Brady LLP

FDA Publishes Final Rule on Regulation of Lab-Developed Tests

Quarles & Brady LLP on

On May 6, 2024 the FDA published its much-anticipated Final Rule on Lab-Developed Tests (“LDTs”) to make explicit that in vitro diagnostic products (“IVDs”) are devices under the Federal Food, Drug, and Cosmetic Act (“FD&C...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q2 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Sheppard Mullin Richter & Hampton LLP

FDA’s Proposed Rule on LDT Regulation and the Debate over Agency Deference

Sheppard Mullin Richter & Hampton LLP on

Earlier this month, the Food and Drug Administration (“FDA” or “the Agency”) issued a highly anticipated proposed rule outlining the regulatory framework and implementation plan for Laboratory Developed Tests (“LDTs”). The...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Issues Long-Awaited Proposed Rule To Regulate Laboratory-Developed Tests

Skadden, Arps, Slate, Meagher & Flom LLP on

On September 29, 2023, the Food and Drug Administration (FDA) issued a proposed rule that would end its long-standing policy of enforcement discretion with respect to regulation of laboratory-developed tests (LDTs) (the...more

Nelson Mullins Riley & Scarborough LLP

FDA Proposes Drastic Overhaul of Laboratory Developed Test Regulation

Nelson Mullins Riley & Scarborough LLP on

Of particular interest to clinical laboratories and medical device manufacturers, the U.S. Food and Drug Administration (FDA or the Agency) released a controversial proposed rule on September 29 that would dramatically alter...more

Morgan Lewis

FDA Issues Long-Awaited Quality System Regulation Amendments

Morgan Lewis on

After four long years and a series of delays, the US Food and Drug Administration released its proposed rule for amending the Quality System Regulation to be harmonized with ISO 13485:2016. In a somewhat surprising move, the...more

Hogan Lovells

New FDA proposed rule will eventually preempt state drug wholesaler/3PL licensure laws

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently announced the proposed rule, “National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers,” which aims to improve the security...more

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