FDA Releases Draft Guidance on Impurity Specifications for Antibiotics
FDA Releases Draft Guidance on Impurity Specifications for Antibiotics The U.S. Food and Drug Administration has issued a draft guidance titled “Establishing Impurity Specifications for Antibiotics.”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...
FDA Releases FY25 Sampling Results on Economically Motivated Adulteration in Honey
FDA Releases FY25 Sampling Results on Economically Motivated Adulteration in Honey The U.S. Food and Drug Administration has released its FY2025 sampling results focused on economically motivated adulteration (EMA) in honey. The sampling program is part of FDA’s...
International Equivalence: What Foreign Governments and Exporters Must Get Right to Access the U.S. Market
Accessing the U.S. market requires more than product compliance. Learn how the FSIS equivalence process works and where foreign inspection systems often fall short.
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....