FDA cites multiple manufacturing and quality control deficiencies at a facility operated by Allergan Pharmaceuticals in Ireland following an inspection last year.
FDA plans a 6/4 town hall meeting aimed at guiding drug developers through the process of preparing BLAs for cell and gene therapy products. The CBER virtual session will feature regulatory experts addressing common questions about BLA readiness and submission strategies.
FDA cites multiple manufacturing and quality control deficiencies at a facility operated by Allergan Pharmaceuticals in Ireland following an inspection last year.
FDA plans a 6/4 town hall meeting aimed at guiding drug developers through the process of preparing BLAs for cell and gene therapy products. The CBER virtual session will feature regulatory experts addressing common questions about BLA readiness and submission strategies.
PhRMA urges FDA to broaden and clarify its draft guidance on individualized therapies, warning that overly narrow definitions and unclear expectations could hinder innovation in precision medicine.
FDA authorizes an expanded access program for an experimental pancreatic cancer therapy from Revolution Medicines, allowing certain patients to receive the drug outside of clinical trials.
