Posted by Michael Wonder on 28 Jul 2023
CDER collaborates with global regulators on pharmaceutical quality assessments and inspections
28 July 2023 - The FDA and the EMA recently completed the first collaborative assessment of a proposed post-approval change for a critical oncology biologic with the Japanese Pharmaceuticals and Medical Devices Agency serving as an observer.
The work, in which FDA and EMA reviewed and approved a proposal to add new manufacturing and quality control sites, can help assure the supply of the medicine.
