FDA has issued a direct final rule updating its regulations to clarify that non-animal testing methods may be used, where appropriate, to establish the safety of drugs and biological products before human clinical trials.
FDA cites Connecticut outsourcing facility Brookfield Medical/Surgical Supplies for inadequate investigations involving 13 out-of-specification potency results.
FDA has issued a direct final rule updating its regulations to clarify that non-animal testing methods may be used, where appropriate, to establish the safety of drugs and biological products before human clinical trials.
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.
