Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: What Industry Needs to Know
When the FDA issues a Form 483 at the conclusion of a drug CGMP inspection, your response becomes a defining regulatory moment. How you address these observations can directly influence outcomes, including the risk of Warning Letters or further enforcement action. In 2026, the FDA released new draft guidance titled “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection.” This will include a focused review of that guidance, breaking down key expectations and what they mean for industry.
Overview of the Coming National Drug Code Format Change
Overview of the Coming National Drug Code Format Change Presented by Victoria Pankovich EAS Consulting Group is hosting a complimentary webinar, Overview of the Coming National Drug Code (NDC) Format Change. The FDA has finalized a rule establishing a uniform 12-digit...
Drug and Device Corner 2026 March
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....
FDA Finalizes Rule Standardizing National Drug Code Format
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....