FDA COVID-19 Announcements
Updates and announcements from the FDA regarding COVID-19 will be posted here as we receive them.
In the News
- FDA Issues Guidance on Policy to Accelerate Availability of COVID-19 Tests
- FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment
- 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
FDA Issues Emergency Use Authorization For Use of Chloroquine Phosphate or Hydroxychloroquine Sulfate
FDA Emergency Use Authorization (EUA) Testing of COVID-19
The FDA list of all current authorized tests, updated daily, is on this page:
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:
Any additional diagnostic questions should be submitted to: COVID19DX@fda.hhs.gov
Any concerns regarding fraudulent products, including tests, should be sent to: FDA-COVID-19-Fraudulent-Products@fda.hhs.gov