Mar 25, 2026 | Drug and Device Corner, Drugs, Medical Devices
2025 CARES reporting deadline is next Tuesday 31 March 2026! The 2026 OMUFA facility registration user fees were published in the 18 March 2026 Federal Register Vol 91, No. 51. There is a lengthy explanation describing how the agency arrived at the user fee amounts....
Feb 24, 2026 | Drug and Device Corner, Drugs, Medical Devices
Reminder that per the CARES Act of 2020, drug establishments are required to report NDC volumes annually. 2025 reports are due no later than 31 March 2026. Reminder that the agency began their policy enforcement late in 2025 contacting facilities that had not reported...
Jan 26, 2026 | Drug and Device Corner
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. 2025 reports are...
Dec 22, 2025 | Drug and Device Corner, Drugs, Medical Devices
Reminder that if the 31 December registration renewal deadline is missed, drug and medical device facility registrations will drop off the public databases. Registrations can be reactivated with a successful renewal submission. Any NDC drug listings that miss the...
Nov 24, 2025 | Drug and Device Corner, Drugs, Medical Devices
For those not already aware, the US government shutdown has ended. The User Fee system is now open and accepting FY2026 payments. The first step for renewal of your Medical Device facility is to pay the FDA FY2026 Medical Device Annual Establishment Registration User...
Oct 28, 2025 | Drug and Device Corner
REMINDER: We are in the drug registration renewal and listing certification period, do schedule your renewal/certification prior to the 31 December 2025 deadline. Facilities that manufacture OTC monograph drugs are reminded that the data pulled for assessing FY2026...
