The guidance discusses how to timely notify the agency of changes in production of APIs and finished products.
The CDMOs are joining together to offer end-to-end development and manufacturing services for protein expression systems and viral vectors in Europe.
The agency will coordinate intra-regional medicines regulation to strengthen the African regulatory network.
The final guidance provides specific recommendations for CMC, pharmacology, toxicology, and clinical study design for CAR-T cell products.
The final guidance provides recommendations for developing gene therapy products incorporating genome editing of human somatic cells.
The agency recommended 77 drugs for marketing authorization in 2023, including 39 new APIs.
FDA’s Center for Drug Evaluation and Research released its report on new drugs approved in 2023.
The agency is reviewing data on secondary malignancies related to T-cells for approved CAR T-cell medicines.
The European Medicines Agency safety committee says there is a potential risk of neurodevelopment disorders in children born to men treated with valproate.
Regulators from around the world will gather to help shape the mRNA and RNA therapeutics landscape at an exceptional April 2024 Washington, D.C. convocation.