Amanda Klingler

Amanda Klingler

King & Spalding

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FDA Publishes More Than 200 Complete Response Letters (CRLs) With More to Come

On July 10, 2025, the Food and Drug Administration (FDA) announced that it had published more than 200 complete response letters (CRLs), in response to applications submitted to the FDA for approval of drugs or biological...more

7/14/2025  /  Capital Markets , Compliance , Disclosure Requirements , Drug Approvals , Food and Drug Administration (FDA) , Investors , Pharmaceutical Industry , Regulatory Requirements , Securities Litigation , Shareholders

FDA Announces Completion of AI-Assisted Scientific Review Pilot and Deployment of Agency-Wide AI-Assisted Review

On May 8, 2025, the Food and Drug Administration (FDA) announced the completion of its generative artificial intelligence (AI) pilot program for scientific reviewers. FDA Commissioner Marty Makary was quoted in the...more

5/20/2025  /  Algorithms , Artificial Intelligence , Biologics , Food and Drug Administration (FDA) , Machine Learning , Medical Devices , Pharmaceutical Industry , Prescription Drugs , Regulatory Agenda , Regulatory Requirements
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