Apr 7, 2026 | Drugs, Webinar
Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: What Industry Needs to Know Presented by Lisa El-Shall and Jeb Hunter May 8, 2026 | 2:00 PM ET When the FDA issues a Form 483 at the conclusion of a drug CGMP inspection, your...
Apr 3, 2026 | Drugs, Webinar
Overview of the Coming National Drug Code Format Change Presented by Victoria Pankovich May 20, 2026 | 1:00 PM ET EAS Consulting Group is hosting a complimentary webinar, Overview of the Coming National Drug Code (NDC) Format Change. The FDA has finalized a rule...
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....
Mar 9, 2026 | Drugs, FDA and USDA Regulatory Update
FDA Finalizes Rule Standardizing National Drug Code Format FDA Final Rule Revises National Drug Code Format and Barcode Requirements FDA has issued a final rule revising the format of the National Drug Code (NDC) and updating certain drug label barcode requirements....
Mar 9, 2026 | Drugs, FDA and USDA Regulatory Update
FDA Issues Guidance on Responding to Form 483 Observations Following Drug CGMP Inspections FDA Releases Guidance on Responding to Form 483 Observations The U.S. Food and Drug Administration has issued a guidance document titled “Responding to FDA Form 483 Observations...
Feb 26, 2026 | Cosmetics, Dietary Supplements, Drugs, FDA and USDA Regulatory Update, Foods, Medical Devices, Tobacco, Veterinary
FDA Highlights Importance of Confidential Information in Maintaining Regulatory Integrity FDA Emphasizes Role of Confidential Information in Its “Gold Standard” The U.S. Food and Drug Administration has published a new FDA Voices article highlighting the importance of...
