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FDA Office of Minority Health and Health Equity

The latest from FDA

Public health emergency response and other updates from FDA since our last email update include: March 28, 2023: FDA Roundup including an Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market March 25, 2023: FDA Roundup including new materials to educate patients about biosimilars March 24, 2023: FDA Issues Final Guidances for COVID-19 Medical Device Transition Plans (more under EUA updates below) March 23, 2023: SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests (updated to add SPERA COVID-19 Ag Test) March 23, 2023: Framework for the Use of Digital Health Technologies in Drug and Biological Product Development Quick links: COVID-19 updates from FDA, FDA Mpox Response

Register now to share your long COVID experience with FDA

Public Meeting on Patient-Focused Drug Development for Long COVID

April 25, 2023

FDA is hosting a virtual public meeting on patient-focused drug development for long COVID. This meeting will provide FDA the opportunity to obtain initial patient and patient representative input on the aspects of long COVID, including how long COVID affects their daily life, symptoms that matter most to patients, their current approaches to treating long COVID, and what they consider when determining whether or not to participate in a clinical trial.

This virtual public meeting will be conducted with live translation in both English and Spanish.

Reunión pública sobre el desarrollo de medicamentos centrados en el paciente contra el COVID-19 persistente

El 25 de abril de 2023

La Administración de Alimentos y Medicamentos de EE. UU. (FDA, por sus siglas en inglés) organizará una reunión pública virtual sobre el desarrollo de medicamentos centrados en el paciente contra el COVID-19 persistente. Esta reunión brindará a la FDA la oportunidad de obtener aportes iniciales de los pacientes y de los representantes de estos sobre aspectos del COVID-19 persistente, como la forma en que afecta la vida diaria, los síntomas que los pacientes consideran de mayor importancia, los enfoques actuales para tratar el COVID-19 persistente y las consideraciones para la participación en estudios clínicos.

Esta reunión pública virtual se llevará a cabo con traducción en vivo tanto en inglés como en español.

Events

• March 28-29, 2023: Public Workshop: Understanding Priorities for the Development of Digital Health Technologies to Support Clinical Trials for Drug Development and Review (virtual)
• March 30, 2023: Immune Globulin Hypersensitivity Reactions: Root Causes and Mitigation Public Workshop (virtual)
• April 17, 2023: Antimicrobial Drugs Advisory Committee meeting (virtual) - The committee will discuss new drug application (NDA) 216974, for sulbactam-durlobactam for injection, submitted by Entasis Therapeutics, Inc. The applicant's proposed indication is for the treatment of infections due to Acinetobacter baumannii-calcoaceticus complex including multidrug-resistant and carbapenem-resistant strains.
• New! April 18, 2023: Webinar on Guidances on COVID-19 Transition Plans for Medical Devices (1:00 - 2:30 p.m. ET) - FDA will host a webinar for stakeholders interested in learning more about the two final guidances on the Coronavirus Disease 2019 (COVID-19) transition plans for medical devices.
• April 24–28, 2023: Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories - To attend virtually, pre-registration by April 14, 2023.
• April 25, 2023: Public Meeting on Patient-Focused Drug Development for Long COVID (virtual) - This virtual public meeting will be conducted with live translation in both English and Spanish. To attend, please register.

Learn more about these events, and see more on the MCMi News and Events page, under Upcoming events.

In case you missed it

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.

Visit the FDA OMHHE website and follow us on Twitter at @FDAHealthEquity

"Creating a world where health equity is a reality for all." www.fda.gov/healthequity