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Administrative Procedure Act Clinical Trials

Ropes & Gray LLP

FDA Makes Good on Promise to Publish CRLs for Unapproved Drugs and Biologics

Ropes & Gray LLP on

On September 4, 2025, the U.S. Food and Drug Administration (“FDA”) announced plans to begin releasing complete response letters (“CRLs”) “promptly” after it issues them to sponsors, rather than waiting until after approval....more

Bradley Arant Boult Cummings LLP

Crank the Party Up: Is the DEA About to Get It On with Psilocybin?

On August 11, 2025, the U.S. Drug Enforcement Administration officially transmitted a request to the Department of Health and Human Services to loosen the federal restriction on psilocybin, seeking to move one of the...more

Husch Blackwell LLP

The Overturning of Chevron Deference: Implications for AI in Medical Research

Husch Blackwell LLP on

In a landmark decision on June 28, 2024, the Supreme Court overturned a 40-year-old legal precedent known as Chevron deference. Established in 1984, Chevron deference mandated that judges defer to federal agencies concerning...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

MarkIt to Market® - April 2022: Watching the Pot™

APA Challenges to DEA Cannabis Policy: "Hot" Hemp and Research-Grade Cannabis - The beginning of spring brought some interesting developments in administrative legal challenges to the U.S. Drug Enforcement Administration...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

MarkIt to Market® - April 2022

Thank you for reading the April 2022 issue of Sterne Kessler's MarkIt to Market® newsletter. This month, we discuss two ongoing administrative legal challenges to the U.S. Drug Enforcement Administration's policies on...more

Troutman Pepper Locke

Clinical Diagnosis of FDA's Clinical Investigation Exclusivity Standard? Unreasonable

Troutman Pepper Locke on

For drug innovators, particularly those focusing on repurposing drugs for new indications and developing drugs that are not considered new chemical entities, understanding the scope of the clinical investigation exclusivity...more

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