Demonstration Program

The CDER Center for Clinical Trial Innovation (C3TI) Demonstration Program provides an opportunity to test and scale the integration of innovative approaches in clinical trials. The program offers a mechanism for early engagement between CDER and sponsors of clinical...

Real-World Evidence Submissions to CDER

As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA VII), FDA committed to reporting aggregate and anonymized information on submissions to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research...

Resources for Health Care Professionals

Health care professionals can play a key role in educating patients about medication health fraud.Key Points to Know When Educating Patients about Medication Health FraudMedication health fraud refers to false or misleading claims about products’ ability to treat...