Drug and Device Corner 2026 August
FDA has announced the OMUFA facility user fee amounts for FY2027 in the Federal Register Vol 91, No. 145 Over-the-Counter Monograph Drug User Fee Rates for Fiscal Year 2027. Please note the change in due date from previous years. FY2027 marks the transition to...
FDA Issues Draft Guidance on Container Closure Systems for Human Drugs and Biological Products
FDA has issued draft guidance with updated CMC and quality recommendations for container closure systems used with human drugs and biological products.
Drug and Device Corner 2026 July
Highlighted Guidance Documents Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs The Food and Drug Administration is announcing the availability of a final guidance for industry titled “Formal...
Drug and Device Corner 2026 June
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...