Jun 29, 2026 | Drug and Device Corner, Drugs, Medical Devices
EAS has become aware of the agency’s increased enforcement policy described in their Guidance Document Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe. For extension requests that identify the same reason for the request multiple...
May 28, 2026 | Drug and Device Corner, Drugs, Medical Devices
Reminder that OMUFA user fee payments are due 1 June 2026. The agency allows a 20-day grace period before publishing facilities on the arrears list. Keep in mind, per regulation, drugs manufactured at facilities identified on the arrears list are considered...
Apr 23, 2026 | Drug and Device Corner, Drugs, Medical Devices
Reminder that the annual GDUFA self-ID submission period begins 1 May 2026. Submissions must be filed during the month of May. EAS can assist with this submission if needed. The 2026 OMUFA facility registration user fees were published in the 18 March 2026 Federal...
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...
