FDA approves Baxters premix norepinephrine bitartrate in 5% dextrose injection, indicated for raising blood pressure in adult patients with severe, ac...
Federal Register notice: FDA makes available a draft guidance for industry #253 entitled Good Manufacturing Practices for Animal Cells, Tissues, and C...
Federal Register notice: FDA announces the availability of a draft guidance for industry #254 entitled Donor Eligibility for Animal Cells, Tissues, an...
FDA announces a 12/3 virtual public workshop entitled Orthopedic Device-Related Infections II Workshop.
FDA warns Malaysias Furley Bioextracts about CGMP violations in its production of OTC drugs and manufacturing a misbranded unapproved new drug.
FDA warns Honduras Laboratorio Pharma International about significant CGMP violations in its manufacturing of OTC drugs and production of a misbranded...
The DC federal court says FDA failed to prepare a necessary regulatory flexibility analysis when it developed a Final Standard Memorandum of Understan...
FDA releases the Biosimilar User Fee Act reauthorization goal letter for FY 2023-2027.