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New Webinar: Preparing and Submitting a Standalone Pre-Existing Tobacco Product Submission

FY2025 Drug Program User Fees

Please see below information regarding FY2025 Drug Program User Fees which go into effect 1 October 2024. The FDA has announced FY2025 user fees for GDUFA, OMUFA (Order Requests only), PDUFA, BsUFA, and animal user fee programs. Please see the Federal Register notices...
New Webinar: Preparing and Submitting a Standalone Pre-Existing Tobacco Product Submission

FY2025 Medical Device Fees

Please see below information regarding FY2025 Medical Device User Fees which go into effect 1 October 2024. Keep in mind, the FY2025 facility user fee must be paid prior to processing your annual renewal during the renewal period Oct 1 – Dec 31. FY2025 Medical Device...