The Food and Drug Administration (FDA) recently announced that it had identified “significant data integrity and study conduct concerns” with bioequivalence studies conducted by the India-based contract research organization...more
On March 3, 2025, the U.S. Department of Health and Human Services (HHS) published a policy statement rescinding a decades-old administrative exemption for notice-and-comment rulemaking known as the Richardson Waiver. Written...more
3/7/2025
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Notice and Comment ,
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Rulemaking Process
On January 7, 2025, FDA published “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff”...more