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FDANonrulemakingFDA-2024-D-3334

Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway; Draft Guidance for Industry; Availability

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Association for Accessible Medicines filed 1 comment on this docket between Mar 4, 2025 and Mar 4, 2025. 0 other organizations filed here. The comment window closed 505d ago.

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Mar 4, 2025· Comment from Association for Accessible Medicines (AAM)· FDA-2024-D-3334-0006

FDA, Please find attached comments from the Association for Accessible Medicines (AAM) regarding Docket No. FDA-2024-D-3334 "Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway; Draft Guidance for Industry" Thanks, Scott Kuzner, Ph.D., Senior Director, Sciences and Regulatory Affairs, AAM

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