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...

Medication Health Fraud

Medication health fraud refers to false or unproven claims about products’ ability to treat health issues, diseases or conditions. These products may also hide dangerous ingredients, including prescription drug ingredients, banned substances and/or harmful...

Medication Health Fraud Notifications

FDA issues notifications to alert consumers when it finds products that are contaminated with hidden ingredients. These contaminated products are a type of medication health fraud and may cause you harm.You can find notifications about dangerous products organized by...