Lauren Roth

Lauren Roth

King & Spalding

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Administrative, Congressional, and State Interest Signal a Potential Breakthrough Moment for Psychedelics

The development of innovative pharmaceuticals targeting refractory mental health conditions has stagnated for decades. In recent years, however, psychedelics have garnered scientific and public attention for their potential...more

6/6/2025  /  Clinical Trials , Department of Health and Human Services (HHS) , Draft Guidance , Drug Pricing , FDA Approval , Food and Drug Administration (FDA) , Mental Health , New Legislation , Proposed Legislation , Research and Development

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CDRH and CBER Release Final Guidance for the Q-Submission Program and Draft Guidance for PreSTAR - On May 29, 2025, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Center...more

6/5/2025  /  Compliance , Draft Guidance , Food and Drug Administration (FDA) , Government Agencies , Medical Devices , New Guidance , Regulatory Agenda , Regulatory Oversight , Regulatory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