Caroline Kessler

Caroline Kessler

Akin Gump Strauss Hauer & Feld LLP

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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

FDA Announces Draft Guidance on Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial Is Underway

On January 6, the FDA announced the availability of draft guidance on accelerated approval for drugs and biological products, and consideration for determining whether a confirmatory trial is underway.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

FDA Announces Draft Guidance for Industry Regarding Accelerated Approval for Drugs and Biologics

On December 5, 2024, FDA unveiled the draft guidance for industry regarding accelerated approval for drugs and biologics. This guidance provides additional information regarding the development of drugs and biologics to treat...more

12/6/2024  /  Biologics , Consolidated Appropriations Act (CAA) , Draft Guidance , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs

Senate HELP Committee Unveils Draft FDA User Fee Reauthorization Legislation, with Major Reforms to In Vitro Diagnostics,...

On May 17 the Senate Health, Education, Labor and Pensions (HELP) Committee released a bipartisan legislative discussion draft of the Food and Drug Administration (FDA) Safety and Landmark Advancements Act (FDASLA), which...more

5/24/2022  /  Biologics , Biosimilars , Food and Drug Administration (FDA) , GDUFA , Generic Drugs , Medical Devices , PDUFA , Prescription Drugs , User Fees
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