Emergency Use Authorization (EUA) Updates

Emergency Use Authorization (EUA) Updates

FDA issues surgical masks umbrella EUA FDA issued an EUA in response to concerns relating to insufficient supply and availability of disposable, single-use surgical masks. As explained in the EUA, surgical masks that meet specific performance requirements are authorized for use in health care settings by health care personnel (HCP) as personal protective equipment (PPE) to provide a physical barrier to fluids and particulate materials to prevent HCP exposure to respiratory droplets and large particles during surgical mask shortages resulting from the COVID-19 pandemic. (August 6, 2020)

FDA revokes EUA for Autobio Diagnostics' Anti-SARS-CoV-2 Rapid Test FDA revoked the EUA (PDF) of the Autobio Diagnostics Co. Ltd.'s Anti-SARS-CoV-2 Rapid Test for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human plasma from anticoagulated blood (Heparin / EDTA / sodium citrate) or serum 2 due to performance concerns with the accuracy of the test. This test may not be distributed. Diagnostic test EUAs To date, FDA has currently authorized 210 tests under EUAs, which include 171 molecular tests, 37 antibody tests, and 2 antigen tests. Also see: Coronavirus Testing Basics

Related links: FAQs on Testing for SARS-CoV-2 (frequently updated) Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices

Events

• Today! August 12, 2020: Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - FDA will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SAR-CoV-2, 12:15 p.m. - 1:15 p.m. ET. FDA will host additional town halls in this series on Wednesdays in August. There is significant interest in this Town Hall. Connecting early is highly recommended. To ensure you are connected, please dial-in at 12:00 p.m. 
• August 13, 2020: FDA Grand Rounds webcast - Nanotechnology: Over a Decade of Progress and Innovation at FDA, 12:00 - 1:00 p.m. ET - Also see the related report (PDF), issued July 2020
• August 18, 2020: Save the date for the next event in the webinar series to share information and answer your questions on respirators and other personal protective equipment (PPE). Printable slides and transcripts from previous events in this series are available.
• September 17-18, 2020: Considerations for the Use of Real-World Evidence to Assess the Effectiveness of Preventive Vaccines - virtual workshop - agenda (PDF)
• October 2, 2020: Vaccines and Related Biological Products Advisory Committee (webcast) - At this meeting the committee will recommend strains for the 2021 Southern Hemisphere influenza vaccines licensed in the U.S., which is part of FDA’s year-round efforts to flight flu, along with other public health partners like CDC and NIH.

In case you missed it

Coronavirus Disease 2019 (COVID-19) Resources for Health Professionals If you have recovered from COVID-19, confirmed by a positive test, you’re in a special position to help us fight the virus. Donate plasma now. Questions about methanol contamination in hand sanitizer? Visit FDA's searchable list to help you identify hand sanitizers that should not be used. In addition, FDA continues to find issues with certain hand sanitizer products. Test results show certain products have concerningly low levels of the active ingredient ethyl alcohol or isopropyl alcohol. Do not use these subpotent products, also on the searchable list. Take our hand sanitizer quiz to test your knowledge! Expiration Date Extension Update Additional Expiration Date Extensions of Certain Lots of Doxycycline Hyclate 100 mg Capsules Held in Strategic Stockpiles On August 7, 2020, FDA issued a memo (PDF) to government public health and emergency response stakeholders extending for the second time the expiration dates of certain lots of doxycycline hyclate 100 mg capsules held in strategic stockpiles for anthrax emergency preparedness and response purposes. Also see: Expiration date extensions of certain lots of doxycycline hyclate

Information for industry

Temporary Guidance for Hand Sanitizers FDA has taken additional action to help ensure that hand sanitizers produced under the agency’s temporary guidances do not contain unsafe levels of methanol. FDA has updated its guidances to provide clarification that companies test each lot of the active ingredient (ethanol or isopropyl alcohol (IPA)) for methanol, if the ethanol or IPA is obtained from another source. FDA has also included an additional denaturant formula in the temporary guidances. Denaturing alcohol in hand sanitizers is critical to deter children from unintentional ingestion. Consumer and health care personnel safety is a top priority for FDA, and an important part of FDA’s mission is to protect the public from harm, especially as we seek to facilitate an increase in the supply of hand sanitizer. (August 10, 2020) Antimicrobial Resistance (AMR) FDA is committed to implementing requirements in the 21st Century Cures Act to help encourage the development of safe and effective drugs for serious bacterial and fungal infections in a limited population of patients with unmet needs. Final guidance on the Limited Population Pathway for Antibacterial and Antifungal Drugs is a part of the larger FDA effort to fight antimicrobial drug-resistant infections and is an integral step in a long-term implementation of the LPAD pathway. (August 5, 2020) An Exciting New Chapter in OTC Drug History: OTC Monograph Reform in the CARES Act 240 million Americans use over-the-counter (OTC) drugs every year. OTC drugs are available to consumers without a prescription and can be safely and effectively used without the supervision of a health care provider. The beginning of an exciting new chapter in OTC drug history began in March when the President signed into law H.R. 748, the “Coronavirus Aid, Relief, and Economic Security Act” or “CARES Act.” The act includes important reforms that modernize the way certain OTC drugs are regulated in the United States. (August 6, 2020) Information for Health Care Facilities and Providers on “in-use time” - COVID-19 FDA is aware that some health care facilities and providers are facing challenges in maintaining adequate supplies of certain drugs needed to treat patients with COVID-19. In particular, health care facilities and providers have reported that care of ventilated patients can be complicated by the need to discard containers of medications before they are fully administered because of the in-use time specified on the FDA-approved label. The “in-use time” is the maximum amount of time that can be allowed to elapse between penetration of a container-closure system containing a sterile drug product, or after a lyophilized drug product has been reconstituted, and before patient administration. Some facilities and providers have indicated that they are considering use of certain drugs, for which supplies may not be consistently available, beyond the labeled “in-use times.” The FDA is committed to providing timely recommendations, regulatory information, guidance, and technical assistance necessary to support rapid COVID-19 response efforts. FDA has issued more than 50 COVID-19-related guidances to date.

COVID-19-Related Guidance Documents