The FDA Compounding Quality Center of Excellence posts 14 questions and answers about compounding inspections and oversight.
FDA approves CellTrans Lantidra, the first cellular therapy to treat some patients with Type 1 diabetes.
Federal Register notice: FDA sends an information collection revision to OMB entitled FDA Advisory Committee Regulations."
Federal Register notice: FDA sends to OMB an information collection revision entitled Accreditation Scheme for Conformity Assessment Program.
FDA releases the form FDA-483 with 11 observations from an inspection at Indias Ipca Laboratories Ratlam API facility.
FDA approves a BioMarin Pharmaceutical BLA for Roctavian (valoctocogene roxaparvovec-rvox) gene therapy for treating adults with severe hemophilia A.
FDA sends Alvotech a complete response letter for its BLA for AVT02, a high-concentration biosimilar candidate referencing AbbVies Humira (adalimumab)...
FDA clears two Roche assays that measure two biomarkers of Alzheimer's pathology beta-amyloid and tau proteins in adults over 55 being diagnosed wit...
