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Regulatory Oversight › Federal Food Drug and Cosmetic Act (FFDCA) › Chevron Deference

Ropes & Gray LLP

Stem Cell Litigation Update: FDA Won the Latest Battle, but the Future of HCT/P Enforcement Remains Unclear

Ropes & Gray LLP on

On September 27, 2024, the U.S. Court of Appeals for the Ninth Circuit reversed the district court’s decision in U.S. v. California Stem Cell Treatment Center, Inc. (“California Stem Cell”), holding that a clinic’s stem cell...more

Epstein Becker & Green

Recent Supreme Court Decisions and the DSCSA

Epstein Becker & Green on

The recent Supreme Court decisions of SEC v. Jarkesy and Loper Bright Enterprises v. Raimondo have the potential to meaningfully impact the implementation and enforcement of the Drug Supply Chain Security Act (“DSCSA”) as...more

Paul Hastings LLP

A Sea Change Looms as FDA Finalizes Its Controversial Regulation Asserting Jurisdiction Over LDTs

Paul Hastings LLP on

On April 29, 2024, after years of false starts trying to expand oversight of laboratory developed tests (“LDTs”) through administrative and legislative actions, FDA announced the much-anticipated—and highly...more

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