U.S. Food and Drug Administration officials have traveled the nation—and the world—to share updates on our accomplishments and work to encourage new advances. We also remain dedicated to assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our food supply, cosmetics, and products that emit radiation.
See what our staff have said about our forward-looking activities.
“Probably the most exciting accomplishment since the enactment of the [Biologics Price Competition and Innovation Act of 2009] is FDA’s approval of the first biosimilar in the United States. On March 6, 2015, FDA approved the first biosimilar, Zarxio (filgrastim-sndz), a biosimilar to Neupogen (filgrastim), a reference product licensed by FDA that is used to help stimulate growth of white blood cells in patients with cancer and help them fight infection."
—Janet Woodcock, M.D., Director of the FDA's Center for Drug Evaluation and Research
Learn more by reading Dr. Woodcock's testimony, Biosimilar Implementation: A Progress Report from FDA.
Biologic and Drug Development
- Implementation of the generic drug user fee amendments of 2012 (GDUFA)
- "The central role of patients in developing products for rare diseases" -- Remarks by Stephen M. Ostroff, M.D.
- Biosimilar Implementation: A Progress Report from FDA
- Recent Developments in Combating Antibiotic Resistance: FDA's Role
- FDA's role in combating prescription drug abuse and misuse
- FDA approves novel cancer therapies and encourages scientific advances
- Examining the Regulation of Diagnostic Tests and Laboratory Operations
- Continuing America's Leadership: The Future of Medical Innovation for Patients
- Continuing America's Leadership: Realizing the Promise of Precision Medicine for Patients
- Optimizing FDA's Regulatory Oversight of Next Generation Sequencing Diagnostic Tests
Other Topics and General Overviews
- Examining the U.S. public health response to the Zika virus
- Remarks of nominee to be Commissioner of the Food and Drug Administration
- "Responding to changing regulatory needs with care and due diligence" -- Remarks to the Regulatory Affairs Professional Society
- Speech by Dr. Stephen M. Ostroff to the Missouri Biotechnology Association
- Priming the innovation pumpâFDA's role in advancing and using next generation sequencing
- Remarks on the 21st Century Cures proposal and FDA's commitment to innovation
- Details on FDA's many accomplishments at the 2015 Annual Conference of the Food and Drug Law Institute
- Lessons Learned: How the FDA Matters
- How FDA facilitates medical innovation for patients
- A look at compliance and innovation during the 12th Annual Pharmaceutical Compliance Congress
- Overview of preparedness and emergency response: FDA fights threats, infectious disease