Caroline Kessler

Akin Gump Strauss Hauer & Feld LLP

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Latest Posts › Regulatory Requirements

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FDA Opens the Vault on Decision Letters—Releases Wave of Drug and Biologic CRLs

This morning, the U.S. Food and Drug Administration (FDA) announced the publication of more than 200 decision letters, also known as complete response letters (CRLs), with plans to release more from the archives. The CRLs...more

7/11/2025 / Biologics , Clinical Trials , Disclosure Requirements , Drug Pricing , Food and Drug Administration (FDA) , Investors , Pharmaceutical Industry , Prescription Drugs , Regulatory Requirements , Transparency

No Appeal of LDT Decision Means Ball Is Back in FDA’s Court for Policy Clarification

Over the weekend, the Department of Justice (DOJ) did not file an appeal of the U.S. District Court for the Eastern District of Texas’ decision to vacate and set aside the agency’s final rule on the regulation of laboratory...more

6/6/2025 / Appeals , Department of Justice (DOJ) , Final Rules , Food and Drug Administration (FDA) , Judicial Authority , Medical Devices , Regulatory Agenda , Regulatory Requirements , Rulemaking Process

District Court Vacates FDA LDT Rule; What’s Next for Regulation of Lab Testing?

On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA. Judge Jordan’s decision vacates and sets...more

4/4/2025 / Appeals , Clinical Laboratories , Final Rules , Food and Drug Administration (FDA) , Healthcare , Judicial Authority , Laboratory Developed Tests , Medical Devices , Regulatory Oversight , Regulatory Requirements

Is Self-Affirming GRAS Off the Menu?

United States Department of Health and Human Services (HHS) Secretary Kennedy recently directed the U.S. Food and Drug Administration (FDA) to consider rulemaking to revise its longstanding regulations and guidance governing...more

3/13/2025 / Department of Health and Human Services (HHS) , Final Rules , Food and Drug Administration (FDA) , GRAS , Proposed Rules , Regulatory Reform , Regulatory Requirements , Rulemaking Process , Transparency

FDA Announces Draft Guidance on Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial Is Underway

On January 6, the FDA announced the availability of draft guidance on accelerated approval for drugs and biological products, and consideration for determining whether a confirmatory trial is underway. Under the Consolidated...more

1/9/2025 / Clinical Trials , Food and Drug Administration (FDA) , Life Sciences , New Guidance , Pharmaceutical Industry , Prescription Drugs , Regulatory Agenda , Regulatory Requirements

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