PDUFA is also helping FDA fulfill its central mission of protecting the public health as the Agency responds to the COVID-19 pandemic. Since the start of the pandemic, FDA has been working with biopharmaceutical companies to accelerate the development of safe and effective COVID-19 therapeutics and vaccines. The Agency has provided timely recommendations, regulatory guidance, and technical assistance to developers of potential treatments and vaccines for COVID-19, including on the use of novel approaches to clinical trials and drug review. FDA has also provided clarity to biopharmaceutical sponsors on how to continue to advance the development of new medicines during the current pandemic. PDUFA has helped support this engagement by ensuring FDA’s human drug review program has the infrastructure, scientific expertise and experience with cutting-edge drug development approaches needed to support continued innovation and inform efficient regulatory decision-making.
(Website updated as of August 24, 2021)