GDUFA IV: Fiscal Years 2028 – 2032

The mission of the Office of Pharmaceutical Quality is to assure that quality medicines are available to the American public. The annual Report on the State of Pharmaceutical Quality is intended to help characterize the quality of the U.S. drug supply chain. Learn more.

Why Not Natural, Houston, Texas, is voluntarily recalling its Why Not Natural Organic Moringa – Green Superfood because they may be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened im

ABBOTT PARK, Ill., Nov. 24, 2025 — Abbott has initiated a medical device correction for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the United States after internal testing determined that some sensors may provide incorrect low glucose readings.

Waltham, Mass. – Slade Gorton & Co., Inc, is recalling lot 3896 of Wellsley Farms Farm-Raised Atlantic Salmon sold in 2-lb bags at BJ’s Wholesale Club stores due to the potential for the product to be contaminated with Listeria monocytogenes.
Although healthy individuals may suffer only short-term s

FDA provides resources on pharmaceutical quality topics, including information on regulations, guidance documents, and compliance programs.

The FDA today published more than 200 decision letters, known as complete response letters (CRLs).