M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality

Prime Food Processing LLC of Brooklyn, NY is voluntarily recalling 2,243 cases of two dessert bun varieties because the packaging does not declare milk in the “Contains” allergen statement as required by the U.S. Food and Drug Administration (FDA). The milk in these products is derived from unsalted

The 21st Century Cures Act formally established a multi-step process for Drug Development Tools (DDT) qualification. Qualification of a DDT is for a specific context of use (COU), and the qualified DDT may be used for the COU by any person in drug or biologics development.

B Braun Medical Inc. updates use instructions for the Streamline Bloodline Set for the Dialog+ Hemodialysis System

New legislation will be required for FDA to continue collecting biosimilar user fees in future fiscal years. Information related to FDA’s preparation for the third reauthorization of BsUFA will be hosted here on this page as it becomes available.

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

Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection