New webinar series for monkeypox test developers starts today | Save the date for BAA Industry Day + more news & events

Public health emergency response and other updates from FDA since our last MCMi email include:

• September 20, 2022: FDA Roundup including a potential cybersecurity risk for the Medtronic MiniMed 600 Series Insulin Pump System
• September 20, 2022: FDA announced a collaboration with NIH for funding opportunities to support small businesses in developing medical device development tools (MDDTs)
• September 16, 2022: FDA Roundup including a warning to consumers about social media trends encouraging people to misuse nonprescription medications
• September 14, 2022: Fact Sheet: HHS Takes Action on Executive Order Launching a National Biotechnology and Biomanufacturing Initiative, including FDA advanced manufacturing initiatives and activities
• September 14, 2022: FDA Commissioner Dr. Robert Califf testified before the U.S. Senate Committee on Health, Education, Labor & Pensions: Stopping the Spread of Monkeypox: Examining the Federal Response. 

Quick links: COVID-19 updates from FDA, FDA Monkeypox Response 

FDA releases additional TPOXX (tecovirimat) virology information

FDA released additional information in publicly posted reviews supporting approval of the new drug application for tecovirimat to describe specific changes in the VP37 proteins of orthopoxviruses (e.g., vaccinia virus and monkeypox virus) that are associated with tecovirimat drug resistance.

FDA is releasing this information to aid the scientific community’s genomic sequencing efforts to support national surveillance of the current monkeypox virus outbreak in the U.S. We believe this additional information will further facilitate the ability to monitor for the development and spread of tecovirimat-resistant virus and therefore is important in promoting public health.

Additional information on FDA’s response to the public health emergency, including summary information on tecovirimat drug resistance, is available here. (September 12, 2022) 

Also see from CDC: Guidance for Tecovirimat Use Under Expanded Access Investigational New Drug Protocol during 2022 U.S. Monkeypox Outbreak (September 15, 2022)

New webinar series: Monkeypox Test Development and Validation

FDA will host regular virtual town halls for monkeypox test developers, where the agency will share information and answer questions from attendees. Join us for the first webinar in this series today, September 21, 2022 (12:05 - 1:00 p.m. ET). 

ICYMI

• The presentation recording, slides, and transcript for the September 14, 2022, Policy for Monkeypox Tests webinar is now available from CDRH Learn (under Specialty Technical Topics)
• Fast Facts on the Intradermal JYNNEOS Monkeypox Vaccine (PDF) is now available in Chinese (Simplified), Korean, Spanish, Tagalog, and Vietnamese (September 15, 2022)  
• On September 14, 2022, FDA Commissioner Dr. Robert Califf  testified before the U.S. Senate Committee on Health, Education, Labor & Pensions: Stopping the Spread of Monkeypox: Examining the Federal Response. 

Reminder: Monkeypox test EUA templates

FDA is providing voluntary templates that test developers may use when validating a test or when submitting an EUA request. Also see: Policy for Monkeypox Tests to Address the Public Health Emergency and FAQs on Testing for Monkeypox

In vitro diagnostic (test) EUAs

As of September 20, 2022, 438 tests and sample collection devices are authorized by FDA under EUAs. These include 301 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 antigen tests, and 1 diagnostic breath test. There are 79 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 19 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 EUAs for molecular OTC at-home tests. FDA has authorized 31 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1,116 revisions to test EUAs. Also see: COVID-19 Test Basics  

COVID-19 vaccines: Bivalent boosters

New: FDA posted to YouTube a recording (45 minutes) of a stakeholder call held on September 2, 2022, to discuss the updated COVID-19 boosters. FDA Commissioner Dr. Robert M. Califf and CBER Director Dr. Peter Marks answer questions from health care providers and other stakeholders.

Focus Areas of Regulatory Science
In September, FDA published the 2022 Focus Areas of Regulatory Science (FARS) report. Updates on FDA research include public health emergency preparedness and response, increasing choice and competition, unleashing the power of data, and much more.

Resources to keep yourself and others safe from COVID-19
Find out where to get a COVID-19 vaccine, test, or treatment in your community at COVID.gov. Call 1-800-232-0233 (TTY 1-888-720-7489) with questions. (Also available in Spanish and Simplified Chinese.)

Expiration date extensions of COVID-19 at-home tests
Check the Expiration Date column of the List of Authorized At-Home OTC COVID-19 Diagnostic Tests to see if the expiration date for your at-home OTC COVID-19 test has been extended and how to find any new expiration date.  

List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 350 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and use our step-by-step search guide to find out if your product is on the list.