FDA: actions related to COVID-19

The latest information on FDA actions related to COVID-19 are available at: https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19#new

At-a-glance: FDA COVID-19 response summary

Medical Devices:

FDA posted a new webpage with frequent questions and answers on importing medical devices during the COVID-19 pandemic

Drug Shortages: FDA updates its webpage on COVID-19 drug shortages responses 

Hand Sanitizers containing methanol: List of recalled hand-sanitizers that contain undeclared methanol as ingredient

Emergency Use Authorizations (EUA):

• FDA authorizes first COVID-19 Test for Self-Testing at Home (NEW)
• FDA revokes EUA for Chloroquine and Hydroxychloroquine
• FDA is reissuing certain EUA to specify which respirators are appropriate for decontamination
  • Respirator models no longer authorized 
  • FDA issues EUA to Decontaminate N95 Respirators
• FDA reissued the EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China to revise one of the eligibility criteria 
• FDA issued an Emergency Use Authorization (EUA) for the investigational antiviral drug remdesevir
  • Warning about a newly discovered potential drug interaction related to the remdesivir
  • Frequently Asked Questions on the EUA for remdesivir
• FDA regularly updates the Emergency Use Authorizations (EUA) for diagnostic tests.

Product-Specific Guidance:

• Chloroquine Phosphate and Hydroxychloroquine Sulfate
• FDA reiterates risks of antimalarial drug use for COVID-19

Abbreviated New Drug Applications (ANDA): Albuterol sulfate inhalation solution 0.021% and 0.042%

Guidelines:

• Exemption and exclusion from certain requirements of the drug supply chain security act during the COVID-19 public health emergency

Serology tests for COVID-19 : The FDA issued an  note about the importance of serology tests for  COVID-19 as well as the situation about firms falsely claiming that their serological tests are FDA approved or authorized, or falsely claiming that they can diagnose COVID-19

Reference links for fraudulent COVID-19 products:

• https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-continues-combat-fraudulent-covid-19-medical-products
• https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-alerts-consumers-about-unauthorized-fraudulent-covid-19-test-kits
• https://www.cdc.gov/niosh/npptl/usernotices/counterfeitResp.html
• https://www.cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html
• https://www.cbp.gov/newsroom/local-media-release/cbp-officers-o-hare-seize-prohibited-medical-test-kits
• https://www.flickr.com/photos/fdaphotos/albums/72157713334402986
• https://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-2019-covid-19-products

R&D: https://www.fda.gov/medical-devices/database-reference-grade-microbial-sequences-fda-argos/fda-argos-sars-cov-2-reference-grade-sequence-data

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Coronavirus Treatment Acceleration Program (CTAC)

Adverse Event Reporting for Medical Devices under EUA or discussed in COVID-19 related guidance document.

Thermal Imaging Systems (Infrared Thermographic Systems / Thermal Imaging Cameras)

FDA encourages recovered patients to donate plasma for development of blood-related therapies

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The Center for Drug Evaluation and Research (CDER) launch a webpage with activities and information related to COVID-19: https://www.fda.gov/drugs/emergency-preparedness-drugs/coronavirus-covid-19-drugs