Angiotensin II Receptor Blockers (ARBs) - A Message for Patients

• Learn about the ongoing recall ARB drug products

FDA’s Biomarker Qualification Program

• Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research, discusses biomarker development, their importance, and the role of the FDA and stakeholders in biomarker qualification. 
• FDA experts help stakeholders who are interested in biomarker research and development to better understand FDA’s Biomarker Qualification Program. 

Biosimilars Patient and Prescriber Outreach Materials

Learn more about biosimilars and the development and approval process.  

FDA Drug Info Rounds

Series of training videos for practicing clinical and community pharmacists.  

GDUFA II Videos and Resources

Increasing consumer access to safe high-quality and affordable generic drugs is a top priority at FDA. In recent years, with the help of user fees from industry and the traditional budget appropriations received from Congress, FDA has approved record numbers of generic drug applications.  The Generic Drug User Fee Amendments (GDUFA) were reauthorized and signed into law by the President on August 18, 2017. The reauthorization, known as GDUFA II, is in effect from October 1, 2017 through September 30, 2022.

In brief videos, FDA staff highlight user fees and the new features in GDUFA II.

Regulatory Science at CDER Videos 

Learn how CDER is advancing regulatory science to protect public health.