Oct 16, 2024 | Drugs, On Demand Webinar
Good ANDA Submission Practices Proactive Planning for the Best Possible Outcomes Presented by Radhika Rajagopalan, Ph.D., EAS Independent Consultant FDA recent draft and final guidance documents related to generic drugs indicate the Agency’s thinking with regards to...
Sep 30, 2024 | Drug and Device Corner, Drugs, Medical Devices
The FDA Drug and Medical Device Registration renewal period begins 1 October 2024. With the drug listing certification period upon us, it is a good time to confirm your NDC listings are all accurate. Any NDC SPL file requiring updates should be done prior to 31...
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....
