Feb 27, 2023 | Drug and Device Corner
The FDA sent email reminders in February re mandatory CARES annual reporting for drug establishments, which are due now. CARES volume reporting has been an annual requirement since passing of the CARES Act in 2020. If you have not already submitted your 2020 and 2021...
Jan 30, 2023 | Drug and Device Corner, Drugs, Medical Devices
On 29 December 2022, the U.S. President signed H.R 2617 – the Consolidated Appropriations Act, 2023 into law which includes the Food and Drug Omnibus Reform Act. Of particular interest in this legislation for EAS drug and device clients, are the following: The...
Dec 22, 2022 | Drug and Device Corner, Drugs, Medical Devices
We wish you all a very happy holiday season and prosperous new year. Reminder of the deadline of 31 December 2022 for the establishment registration and product listing renewal period. For those that have not already submitted their CARES Act reporting for FY2020 and...
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...
