Sep 9, 2024 | Drugs, FDA and USDA Regulatory Update
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...
Aug 28, 2024 | Drug and Device Corner, Drugs, Extra Article, Medical Devices
FDA issued a proposed administrative order to amend the requirements for internal analgesic, antipyretic, and antirheumatic drug products for OTC human use, as currently described in OTC Monograph M013. The proposed change will require the addition of a warning to the...
Aug 1, 2024 | Cannabis, Cosmetics, Dietary Supplements, Drugs, Foods, Issue of the Month, Medical Devices, Tobacco, Veterinary
How to Build an Achieving Team By Eiman Raouf, EAS Senior Regulatory Consultant Upon entering various organizations, scenarios often unfold where operational efficiency falls short. Quality lapses in production, a surge in customer grievances, or perpetual crisis...
Jul 25, 2024 | Drug and Device Corner, Drugs, Medical Devices
FDA has sent notices to drug establishment registrants reminding OTC hand sanitizer manufacturers who entered the market solely to provide hand sanitizer during the COVID-19 public health emergency, that beginning FY2025 OMUFA facility user fees will become mandatory....
Jul 1, 2024 | Drug and Device Corner, Drugs, Medical Devices
Final reminder that CARES Act drug amount reports for 2023 are due by 31 July 2024. If you need assistance with this process, reach out to Victoria Pankovich for support. The FDA announced the availability of a final guidance for industry titled “Facility Readiness:...
Jun 17, 2024 | Cosmetics, Dietary Supplements, Drugs, Foods, Issue of the Month
Product Claim Substantiation By Jay Ansell, EAS Independent Consultant Substantiating a product claim is required by U.S. law and can help brands avoid regulatory action or provide an effective defense in litigation. For example, in April 2023, the US Federal Trade...
