Lauren Roth

Lauren Roth

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 Issues Two Guidances For the Device Q-Sub Process

CDRH and CBER Release Final Guidance for the Q-Submission Program and Draft Guidance for PreSTAR - On May 29, 2025, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Center...more

6/5/2025  /  Compliance , Draft Guidance , Food and Drug Administration (FDA) , Government Agencies , Medical Devices , New Guidance , Regulatory Agenda , Regulatory Oversight , Regulatory Requirements , Rulemaking Process
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