Facilitating development and availability of medical devices

Working to facilitate development and availability of medical products for patients, physicians, healthcare systems as expeditiously and safely as possible

  • Emergency Use Authorizations (EUAs): Quickly allowing unapproved medical products to reach patients in need when there are no adequate, FDA-approved alternatives
  • Deal with supply issues
  • Updated website


Facilitating development and availability of drugs 

Coronavirus Treatment Acceleration Program (CTAP) to expedite the development of potential COVID-19 therapies

  • Several therapies currently being tested in clinical trials to evaluate whether
    they are safe and effective in combating COVID-19
  • National effort to facilitate the development of, and access to, investigational therapies derived from human blood
  • Make treatment options available to patients and providers who are not able to participate in clinical trials through expanded access under investigational drug (IND) applications


New Actions to Accelerate Development of Novel Prevention, Treatment Options for COVID-19

> 130 clinical trials of potential COVID-19 related treatments and additional development programs for other agents are in the planning stages

  •  FDA has started to receive data from clinical studies and expects to receive more
  • Agency intends to engage with pharmaceutical sponsors and other government partners for expedited patient access when favorable results

2 Guidances


Surveillance inspections during COVID-19

CDC collaboration to develop a process to return to on-site facility surveillance inspections in accordance with White House Guidelines for ‘Opening Up America Again’

  • First protect health and well-being of workforce and state contract inspectors as well as industry  health of workers
  • Communications with industry as well as domestic and foreign regulatory counterparts
  • Leadership team meet daily to discuss the urgent issues related to drugs/devices, medical and food product supply chains, leverage public health tools
  • Closely monitor global situation and remain in contact with domestic and foreign regulatory counterparts