Drug and Device Corner 2026 May
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...
Drug and Device Corner 2026 April
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...
FDA Releases Draft Guidance on Impurity Specifications for Antibiotics
FDA Releases Draft Guidance on Impurity Specifications for Antibiotics The U.S. Food and Drug Administration has issued a draft guidance titled “Establishing Impurity Specifications for Antibiotics.” The guidance provides recommendations for manufacturers on...
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 In 2026, the FDA released new draft guidance titled “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection.”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.
