Nov 22, 2022 | Drug and Device Corner
Reminder that December is the deadline for the establishment registration and product listing renewal period. Kindly note the FDA has tightened up their validation process for drug listings. Although repack / relabeled listings have been submitted in the past without...
Oct 26, 2022 | Drug and Device Corner, Drugs, Medical Devices
As many are aware, FY2023 FDA user fees were pending authorization from Congress which did not happen until 30 September 2022. As a result, the user fees were announced in early October 2022. Please see Federal Register links and screen shots of fee tables below....
Sep 27, 2022 | Drug and Device Corner, Drugs, Medical Devices
As of 26 September 2022, the U.S. Congress has yet to pass the FDA user fees bill for FY2023 which begins 1 October 2023. EAS will keep our client based informed as this situation develops. EAS wishes to announce the retirement of Ms. Susan Crane, EAS Independent...
Aug 30, 2022 | Drug and Device Corner, Drugs, Medical Devices
Reminder that the establishment registration and product listing renewal period begins 1 October 2022. Contact Victoria Pankovich, vpankovich@easconsultinggroup.com if you would like EAS to handle this process for you. We can pre-schedule an appointment in October,...
Jul 28, 2022 | Drug and Device Corner, Drugs, Medical Devices
EAS bids a fond farewell to Mr. Bryan Coleman, and welcomes Mrs. Lisa El-Shall as our new Sr. Director Pharmaceutical and Medical Device Consulting Services. Lisa can be reached at lelshall@easconsultinggroup.com, 571-447-5504. The FDA has finalized the UDI draft...
Jul 6, 2022 | Drug and Device Corner, Drugs, Medical Devices
The FDA is tightening up the validation process in their NDC drug listing system CDER Direct. Prior to 2022, Relabelers and Repackers were able to list their products NDC/label without identifying the source NDC. As of 2022, the drug listing of a repackaged or...
