Federal Register notice: FDA announces a 12/8 Cardiovascular and Renal Drugs Advisory Committee meeting to discuss a Reata Pharmaceuticals NDA for its...
A CDC advisory panel recommends most of FDAs just-amended emergency use authorization (EUA) for Pfizer-BioNTechs Covid-19 vaccine booster, leaving off...
Federal Register notice: FDA makes available a draft guidance for industry #253 entitled Good Manufacturing Practices for Animal Cells, Tissues, and C...
Federal Register notice: FDA announces the availability of a draft guidance for industry #254 entitled Donor Eligibility for Animal Cells, Tissues, an...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...