Early Alert: Stent and Electrocautery-Enhanced Delivery System Issue from Boston Scientific

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.

By clarifying FDA’s regulatory expectations for new entrants and experienced drug developers alike, FDA is supporting prospective generic drug developers and improving the overall quality of ANDAs submitted to the Agency for approval.

LANSING, Mich. – (BUSINESS WIRE) – Neogen Corporation (NASDAQ: NEOG) is voluntarily recalling all lots within expiry of Neogen®Vet HYCOAT® Hyaluronate Sodium Sterile Solution, for use in dogs, cats, and horses, to the veterinarian level. Neogen distributes this product, which is manufactured by a th

FDA has identified several issues over the past few years related to repackers of bulk drug substances, also called active pharmaceutical ingredients (APIs), used to compound drugs. The agency urges compounders to know your bulks supplier and know if they are testing the drugs before you purchase bu

Unapproved New Drugs/Misbranded

Guidance documents are prepared for FDA review staff and applicants/sponsors to provide guidelines to the processing, content, and evaluation/approval of applications and also to the design, production, manufacturing, and testing of regulated products.