The Latest from FDA

Important public health and other updates from FDA: 7 Things to Know About Drug Shortage Management (October 15, 2024) Consumer Update: It’s a Good Time to Get Your Flu Vaccine (October 15, 2024)  Fact Sheet: HHS Actions to Support Response to Marburg Outbreak in Rwanda (HHS, October 7, 2024) The FDA Office of Women’s Health (OWH) released its updated Women’s Health Research Roadmap, including a priority to combat emerging health threats. (October 3, 2024) Updates on Highly Pathogenic Avian Influenza (HPAI) (October 3, 2024) See more below, and at FDA press announcements.

Supply Chain Updates

Hurricane Helene: Baxter's Manufacturing Recovery in North Carolina

The FDA is working continuously to address the shortages and supply disruptions to ensure patients have access to certain parenteral drugs, including IV solutions. 

The FDA issued an immediately-in-effect guidance, Temporary Policies for Compounding Certain Parenteral Drug Products, for compounders to help fill the gaps from the impact of Hurricane Helene on Baxter International’s North Cove facility. The FDA also added three new drug products to the Drug Shortages Database as a result of Hurricane Helene. The agency now considers Dextrose 70% IV solution, Lactated Ringer's IV Solution, and Peritoneal Dialysis Solution to not be commercially available in adequate supply to meet national demand. (October 11, 2024)

Respiratory Virus Updates

FDA Authorizes Marketing of First Home Flu and COVID-19 Combination Test Outside of Emergency Use Authorities

The FDA granted marketing authorization for the Healgen Rapid Check COVID-19/Flu A&B Antigen Test. The test, authorized for use without a prescription, is for use by individuals experiencing respiratory symptoms and uses a nasal swab sample to deliver at-home results in approximately 15 minutes for COVID-19 and influenza (flu). The test detects proteins from both SARS-CoV-2 (the virus that causes COVID-19) and influenza A and B (the viruses that causes flu).

This is the first over-the-counter (OTC) test that can detect influenza to be granted marketing authorization using a traditional premarket review pathway, which enables the test to be marketed in the absence of an applicable emergency use declaration. Other OTC flu/COVID tests are currently available under emergency use authorization. (October 7, 2024)

New Videos: Respiratory Virus Season

Your Fall Vaccine Game Plan: COVID, Flu, & RSV Protection

As we enter into the respiratory virus season, now is the time to review your game plan. Prevention is the best play. Masks and handwashing can help protect against the spread of respiratory viruses. Watch the video. (1 minute, 20 seconds)

FREE COVID Tests Are Back! How to Order Yours Today

Here’s a quick update on the at-home testing options available for respiratory illness. For COVID-19, each U.S. household may order up to four tests at no charge. If you haven’t already, go to COVIDtests.gov to order yours today. Watch the video. (40 seconds)

Emergency Use Authorization (EUA) Updates

EUA Revocations FDA revoked the following EUAs for the reasons noted in the revocation letters (PDFs):  October 9, 2024: Cue COVID-19 Test for Home and Over The Counter (OTC) Use and Cue COVID-19 Test (Cue Health, Inc.) October 1, 2024: B. Braun Space and Outlook Pumps (B. Braun Medical, Inc.)

Quick Links

• Emergency Use Authorization - about EUAs, and links to current EUAs
• EUAs for Drugs and Non-Vaccine Biological Products (CDER)
• EUAs for Medical Devices (CDRH)
• COVID-19 Vaccines, including vaccine-specific pages with EUA info (CBER)
• COVID-19 Tests Granted Traditional Marketing Authorization by the FDA
• Emergency Use Authorization--Archived Information - EUAs that are no longer in effect because they have been terminated or revoked
• Historical Information about Device EUAs

Events

• October 16, 2024: Advancing Rare Disease Therapies Through an FDA Rare Disease Innovation Hub (Silver Spring, MD or virtual)
• October 24, 2024: FDA’s Total Product Life Cycle Approach to In Vitro Diagnostic Products (IVDs) (webcast)
• October 30, 2024: Finding Your Support Team While Participating in a Clinical Trial (virtual) - Featuring patients, care partners, and advocates who have direct experience building and managing support networks while navigating and participating in clinical trials.
• October 30, 2024: Patient Engagement Advisory Committee (virtual) - The committee will discuss and make recommendations on patient-centered informed consent in clinical study of FDA-regulated medical products.
• November 7, 2024: 16th Annual Sentinel Initiative Public Workshop (Washington, DC or virtual)
• November 8, 2024: Informed Consent – More than Just Another Document to Sign? (virtual) - To provide patients and researchers with an overview of FDA’s expectations for informed consent.
• November 17, 2024: 2024 FDA Broad Agency Announcement (BAA) Day (virtual) - Learn more about the agency-wide BAA for research and development to support regulatory science and innovation. Advance registration required.

Information for Industry and Health Care Providers

In a September webinar, clinicians heard directly from the FDA, Substance Abuse and Mental Health Services Administration (SAMHSA), National Institute on Drug Abuse, National Institutes of Health (NIDA/NIH) and the Agency for Healthcare Research and Quality (AHRQ) about the latest in overdose prevention.
View the recording (57 minutes) and subscribe to receive invitations to future events.

In Case You Missed It

Quick COVID-19 Resources Order free at-home tests at COVIDtests.gov Check expiration date extensions for your COVID-19 tests  Get the latest on COVID-19 vaccines Know your treatment options for COVID-19

COVID-19, Flu and RSV Information for Consumers Your guide to FDA-authorized and approved vaccines, tests and treatments for flu, COVID-19, and RSV (respiratory syncytial virus). Talk with a health care professional about what works best for you.

FDA in Your Day Learn about how the FDA's work impacts you in this series of short videos featuring FDA leadership.

Q&A with FDA Podcast In this podcast series, the FDA’s Division of Drug Information answers some of the most commonly asked questions received by FDA. Previous episodes include conversations about real-world evidence, AI in clinical trial design, drug shortages, and much more.