FDA COVID-19 Announcements

Updates and announcements from the FDA regarding COVID-19 will be posted here as we receive them. 

• Daily FDA Updates
• FDA Press Announcements
• Track clinical trials

In the News

• FDA Revises Patient and Provider Fact Sheets for Moderna and Pfizer Vaccines Regarding Increased Risks of Myocarditis and Pericarditis

• FDA Authorizes Subcutaneous Injection of Regeneron COVID-19 Antibody Treatment; New Formulation

• FDA Authorizes Longer Time for Refrigerator Storage of Thawed Pfizer-BioNTech COVID-19 Vaccine

• FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents

• FDA to Hold Advisory Committee Meeting to Discuss Pediatric Use of COVID-19 Vaccines

• FDA Issues Roadmap for Future State of Inspection and Assessment Operations

• FDA and CDC Lift Pause on Johnson & Johnson Vaccine After Safety Review

• FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab

• Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home 

• Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19 

• Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19

• FDA Authorizes Monoclonal Antibody for Treatment of COVID-19 
• LabCorp Receives FDA Green Light for a New Type of COVID-19 Test Using Fewer Regents 
• FDA Issues Rare Emergency Authorization for an Algorithm Used to Inform Covid-19 Care 
• Emergency Use Authorization for Vaccines to Prevent COVID-19 
• COVID-19 Update: FDA Authorizes First Point-of-Care Antibody Test for COVID-19
• FDA Delays Collection of Drug Manufacturing Volume Data 
• COVID-19 Update: FDA Broadens Emergency Use Authorization for Veklury (remdesivir) to Include All Hospitalized Patients for Treatment of COVID-19 
• FDA Clears Saliva Test for Covid-19 Opening Door to Wider Testing 
• Gilead Seeks US Approval For COVID-19 Treatment Remdesivir 

• Investing in Advanced Manufacturing to Support Public Health Preparedness

• FDA Withdraws Emergency Use Authorization for Hydroxychloroquine

• FDA Publishes Guidance on Institutional Review Board Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During COVID-19 Public Health Emergency  

• Insight into FDA’s Revised Policy on Antibody Tests: Prioritizing Access and Accuracy

• Coronavirus (COVID-19) Update: FDA Continues to Combat Fraudulent COVID-19 Medical Products

• FDA Issues Guidance on Policy to Accelerate Availability of COVID-19 Tests
• FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment 

• FDA Product-Specific Guidances for Chloroquine Phosphate and Hydroxychloroquine Sulfate

• FDA Cautions Against Use of Hydroxychloroquine or Chloroquine for COVID-19 Outside of the Hospital Setting or a Clinical Trial Due to Risk of Heart Rhythm Problems
• FDA Approves First Generic of a Commonly Used Albuterol Inhaler 
• FDA Postpones Foreign Inspections Over COVID-19, Potentially Throwing off Product Approval Timelines 
• FDA New Guidance on Patient Access to REMS Medications  
• FDA Approves BMS’ MS Drug, Launch Delayed by COVID 19; Pfizer Halts New Studies 

FDA Continues to Accelerate Development of Novel Therapies for COVID-19 

• Press release

FDA Issues Emergency Use Authorization For Use of Chloroquine Phosphate or Hydroxychloroquine Sulfate 

• FDA authorization letter 

• HHS press release  

FDA Emergency Use Authorization (EUA) Testing of COVID-19

The FDA list of all current authorized tests, updated daily, is on this page:

• https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd

These FDA pages address available diagnostic and therapeutic medical devices to diagnosis and respond to COVID-19:

• Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices
• Personal Protective Equipment EUA
• In Vitro Diagnostic EUAs

As of March 29, 2020:

• There is no “Home Test” authorized for SARS-CoV-2 (COVID-19).
• There are emergency use authorized (EUA) point of care (POC) tests, but these tests are not CLIA waived. 

Laboratories and Manufacturers that are Offering Tests for COVID-19:

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2#offeringtests

Any additional diagnostic questions should be submitted to: View Email Address

Any concerns regarding fraudulent products, including tests, should be sent to: View Email Address

FDA Guidance

• COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders

FDA Emergency Use Authorization for the emergency use of the Battelle CCDS Critical Care Decontamination System

• FDA Emergency Use Authorization (EUA) for the emergency use of the Battelle CCDS Critical Care Decontamination System™ for use in decontaminating compatible N95 or N95-equivalent respirators (“compatible N95 respirators”) for reuse by healthcare personnel