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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

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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

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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


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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

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