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  1. Coronavirus Disease 2019 (COVID-19)

FDA COVID-19 response infographic

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FDA COVID-19 response infographic (partial image)

 

This infographic provides a snapshot of some FDA COVID-19 response actions through the end of fiscal year (FY) 2021. For more information about FDA's COVID-19 response activities in FY 2021, see the FY 2021 MCMi Program Update. For the latest information about FDA's COVID-19 response, visit www.fda.gov/coronavirus. 

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Text version of infographic

From the beginning of the COVID-19 public health emergency through the end of FY 2021 (September 30, 2021), FDA activities include:

Regulatory advice & guidance

  • Issued 75+ COVID-19-related guidance documents
  • Published 10 diagnostic tests and 3 other medical device EUA templates
  • Reviewed 470+ trials for COVID-19 therapeutics
  • Worked with sponsors on 640+ drug development programs in planning stages

COVID-19 MCM (medical countermeasure) approvals*

*FDA-approved, licensed, or cleared

  • 1 vaccine

  • 1 treatment
  • 1,000+ generic drug approvals for COVID-19 related treatments and supportive therapies
  • 1 diagnostic test
  • 492 personal protective equipment (PPE)
  • 77 other devices

Addressing fraud

  • 1,500+ fraudulent and unproven products related to COVID-19 identified
  • 260 warning letters sent to sellers
  • 393 fraudulent test kits reported
  • 320 online marketplace abuse complaints addressed
  • 312 domain registrar abuse complaints addressed

EUAs (Emergency Use Authorizations)

470+ EUAs issued enabling access to 750+ products

  • 3 vaccines
  • 13 drug and biological therapeutic products
  • 390+ diagnostic tests and sample collection devices
  • 18 PPE
  • 44 other devices

Communications

  • 370+ COVID-19 update press releases
  • 450+ new FDA web pages
  • 11 Consumer Updates
  • 15+ videos for consumers
  • 16+ podcast episodes
  • Thousands of tweets

Stakeholder engagement

  • 80+ MCMi email updates + hundreds more stakeholder emails
  • 80 town halls on testing and PPE
  • Answering public questions
  • 23,515 on COVID-19 drugs 
  • 410,000+ on COVID-19 devices, including testing
  • 11,168 on COVID-19 vaccines
  • Engaged with 2,200+ manufacturers on issues including manufacturing capacity and supply chain issues
     

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