MATTB provides assistance and training through outreach to industry. A: CDER's Division of Drug Information (DDI) serves as a focal point for public inquiries regarding human drug products.

On December 12, 2024, FDA’s Center for Drug Evaluation and Research (CDER) announced a new CDER Center for Real-World Evidence Innovation (CCRI). The CCRI is intended to serve as the focal point ...

With artificial intelligence (AI) becoming more and more common in drug development since 2016, the U.S. FDA is now issuing its first draft guidance on that use. The “FDA recognizes the increased use ...