FDA cites Connecticut outsourcing facility Brookfield Medical/Surgical Supplies for inadequate investigations involving 13 out-of-specification potency results.
Staff from FDA and several drug companies use a Journal of Regulatory Affairs article to explain a 2024 FDA guidance on optimizing EDDO control strategies for drug/biologic combination products.
FDA cites Connecticut outsourcing facility Brookfield Medical/Surgical Supplies for inadequate investigations involving 13 out-of-specification potency results.
Staff from FDA and several drug companies use a Journal of Regulatory Affairs article to explain a 2024 FDA guidance on optimizing EDDO control strategies for drug/biologic combination products.
A new report by CDER’s Office of Clinical Pharmacology says regulatory science will have to evolve alongside increasingly complex therapies, with greater use of quantitative modeling, artificial intelligence and translational evidence expected to play a role in future drug development and regulatory decisions.
FDA’s proposed drug user fee commitments could give drug and biologics sponsors several new opportunities to address manufacturing facility problems before they delay approvals or result in complete response letters, according to an analysis from Arnold & Porter.
