Feb 6, 2024 | Drugs, FDA and USDA Regulatory Update
The FDA has issued a draft guidance document discussing Quality Considerations for Topical Ophthalmic Drug Products intended for topical use in and around the eye. This is an update to the draft guidance of the same name released in October 2023. The guidance...
Jan 29, 2024 | Drug and Device Corner, Drugs, Medical Devices, Uncategorized
Reminder that per the CARES Act of 2020, drug establishments are required to report NDC volumes annually. This applies to all facilities that manufacture, prepare, propagate, compound, or process drugs for commercial distribution in the United States. Although the FDA...
Jan 24, 2024 | Drugs, FDA and USDA Regulatory Update, Veterinary
The FDA has announced the availability of a draft guidance for industry #286 (VICH GL60): “Good Manufacturing Practice for Active Pharmaceutical Ingredients used in Veterinary Medicinal Products.” This draft guidance has been developed by the International Cooperation...
Nov 29, 2023 | Drug and Device Corner, Drugs, Medical Devices
Reminder that 31 December is the deadline for submitting your drug registration renewal, medical device establishment registration renewal and drug listing certification. If NDC listing blanket certification is not submitted, each individual SPL file will need to be...
Sep 25, 2023 | Drug and Device Corner, Drugs, Medical Devices
Reminder that FY2024 GDUFA payments are due 2 October 2023. The FDA does allow a 20 calendar day grace period, after which arrears lists will be published with the names of companies that have failed to make payment. Failure to pay required user fees by this deadline...
Aug 28, 2023 | Drug and Device Corner, Drugs, Medical Devices
We will be entering the establishment renewal and product listing certification period soon. As your regulatory support partner, EAS is here for any questions you may have. If you wish for us to handle the annual requirements, please email Victoria Pankovich to get...
