Advanced manufacturing updates | Register now for March and April events

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

• March 7, 2023: FDA Roundup including revision of the umbrella EUA for disposable, single-use surgical masks intended for use in health care settings by health care professionals during the COVID-19 pandemic
• March 3, 2023: FDA Roundup including registration information for the upcoming training course: Achieving Data Quality and Integrity in Maximum Containment Laboratories
• March 3, 2023: From our perspective: FDA actions to continue to ensure the safety of the nation’s drug supply
• March 2, 2023: Draft guidance: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens
• March 1, 2023: ICH final guidance: Q13 Continuous Manufacturing of Drug Substances and Drug Products
• March 1, 2023: Discussion Paper: Artificial Intelligence in Drug Manufacturing (PDF)
• March 1, 2023: Video: Why should I get my child an updated COVID-19 vaccine? (updated)

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

FDA advances regulatory framework for continuous manufacturing and AI in drug manufacturing

FDA issued the ICH final guidance, Q13 Continuous Manufacturing of Drug Substances and Drug Products and a discussion paper for stakeholder comment, Discussion Paper: Artificial Intelligence in Drug Manufacturing (PDF). These documents represent proactive steps FDA is taking to facilitate the pharmaceutical industry’s adoption of these advanced manufacturing technologies. FDA has long supported advanced manufacturing technologies that might improve process quality and address underlying causes of drug shortages and recalls. FDA is asking interested stakeholders to provide input on certain areas of consideration identified in the discussion paper by May 1, 2023. (March 1, 2023)

Public workshop: Advanced Manufacturing and Analytical Technologies for Regenerative Medicine Therapies

On March 14, 2023, FDA will hold a virtual public workshop: Advanced Manufacturing and Analytical Technologies (AMAT) for Regenerative Medicine Therapies (RMT) for FDA staff and cell and gene therapy stakeholders to discuss innovative manufacturing technologies and alternative testing methods, and share experiences, challenges, and best practices critical for chemistry, manufacturing, and controls (CMC) of cellular and gene therapies and tissue engineered medical products. Please register in advance.

FDA revises umbrella EUA for surgical masks during COVID-19 in response to stabilized supply

FDA revised the EUA for disposable, single-use surgical masks intended for use in health care settings by health care professionals during the COVID-19 pandemic. The revision authorizes emergency use of only those surgical masks listed in the EUA’s Appendix A as of the date of this reissuance. As a result of this revision, the FDA will no longer be adding surgical mask models to Appendix A. Manufacturers who would like to bring new surgical masks to market should follow traditional premarket pathways, such as a premarket notification, or 510(k). Manufacturers can refer to the FDA’s guidance on surgical masks for further information. (March 6, 2023)

COVID-19 in vitro diagnostic (test) EUAs

As of March 7, 2023, 444 tests and sample collection devices are authorized by FDA under EUAs. These include 299 molecular tests and sample collection devices, 84 antibody and other immune response tests, 60 antigen tests, and 1 diagnostic breath test. There are 78 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, 28 EUAs for antigen over-the-counter (OTC) at-home tests, and 5 EUAs for molecular OTC at-home tests. FDA has authorized 45 antigen tests and 8 molecular tests for serial screening programs. FDA has also authorized 1,274 revisions to diagnostic EUA authorizations. Also see: COVID-19 Test Basics  

MCMi FY 2022 Program Update
In February, FDA published the Medical Countermeasures Initiative (MCMi) Program Update report for fiscal year 2022, which showcases FDA's work each year to prepare for all types of public health emergencies. Download a printable PDF. 

COVID-19 at-home tests
Check 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. Bookmark our guide: Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results, and report your positive or negative test results at MakeMyTestCount.org. 

What happens to EUAs when a public health emergency ends?
There are several types of declarations and determinations related to emergencies, including public health emergencies, which serve different purposes. Learn more in this FAQ. Also see, from HHS, Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap. 

Update your antibodies
The virus that causes COVID-19 changes over time. Get your updated COVID-19 vaccine to help protect against COVID’s worst outcomes. Search in your zip code to find a location where a bivalent COVID-19 vaccine booster dose is available near you. 

List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 380 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.