FDA COVID-19 response infographic
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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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