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The Latest from FDA
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Important public health and other updates from FDA:
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FDA’s Unified Human Foods Program, New Model for Field Operations and Other Modernization Efforts Go into Effect (October 1, 2024) (also see FDA Modernization Update below)
- The HHS Secretary declared a public health emergency for Florida, Georgia, North Carolina, South Carolina and Tennessee to address the health impacts of Hurricane Helene. HHS, FDA and other U.S. government partners are working closely with medical product manufacturers impacted by the storm to help monitor and mitigate supply chain impacts. (September 26-30, 2024)
- The FDA provided an update about ongoing research efforts (PDF) it is undertaking to help ensure the safety of dairy products during the outbreak of Highly Pathogenic Avian Influenza A (H5N1) virus in dairy cattle and to work towards reducing the threat of H5N1 to human and animal health. (September 26, 2024)
- The FDA published a digital health and artificial intelligence glossary as an educational resource to help support consistent use of digital health and artificial intelligence terminology by the FDA and interested parties. (September 26, 2024)
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FDA Approves Nasal Spray Influenza Vaccine for Self- or Caregiver-Administration (September 20, 2024)
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Information About the Updated COVID-19 Vaccines (September 18, 2024)
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Key Facts About Vaccines to Prevent Mpox Disease (updated) (September 11, 2024)
More: FDA press announcements
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FDA Modernization Update
The FDA reorganization to help build a stronger, more integrated and modernized agency is effective today, October 1, 2024.
Office of Public Health Preparedness and Response (OPHPR)
The FDA reorganization established an Office of the Chief Medical Officer (OCMO) in the Office of the Commissioner to strengthen central coordination of cross-agency medical issues, including special populations such as people with rare diseases and children. This includes a new Office of Public Health Preparedness and Response (OPHPR) to support medical countermeasure policy, emergency preparedness work and medical product shortage coordination across the agency.
We will also pilot a new online consumer complaint form to both improve the consumer experience when submitting complaints as well as internally handle complaints more efficiently and effectively, helping the FDA to better detect and respond to emerging public health risks.
Subscription info: If you subscribed directly to the previous FDA Medical Countermeasures Initiative (MCMi) newsletter, you will automatically receive OPHPR updates. If someone forwarded you this message, you may subscribe to Public Health Preparedness and Response updates, or review your preferences in our subscription management center.
Office of Regulatory and Emerging Science (ORES)
The Office of Counterterrorism and Emerging Threats (OCET) and the Office of Regulatory Science and Innovation (ORSI) have merged to form a new office within FDA’s Office of the Chief Scientist (OCS). This new office, the Office of Regulatory and Emerging Science (ORES), will strengthen support of regulatory science and preparedness research efforts.
Subscription info: To receive updates from ORES including medical countermeasure-related research news, funding announcements, advanced manufacturing updates, and professional development opportunities, subscribe to What's New in Science and Research.
FDA in Your Day: Some Vaccines are Too New?
 Vaccines are the best way to protect yourself from getting certain diseases. But some people worry that some vaccines – like RSV and COVID-19 – are ‘just too new.’ While it’s natural to think about this, it's the FDA's job to determine their safety and effectiveness before they can be used in the U.S. and before your health care provider recommends them. (video: 1 minute)
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Emergency Use Authorization (EUA) Updates
FDA Updates Pemgarda’s SARS-CoV-2 Variant Susceptibility Data
The FDA revised the Fact Sheet for Health Care Providers (PDF) with new SARS-CoV-2 variant susceptibility data for Pemgarda (pemivibart), including data on variants KP.3.1.1 and LB.1. The FDA will continue to provide updates on variant susceptibility to assist prescribers and patients who utilize Pemgarda for pre-exposure prevention of COVID-19.(September 26, 2024) More information and resources about Pemgarda
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Quick links
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Events
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October 10, 2024: Vaccines and Related Biological Products Advisory Committee (virtual) - The committee will discuss and make recommendations on the strain selection for the influenza virus vaccines for the 2025 southern hemisphere influenza season, and discuss pandemic preparedness for highly pathogenic avian influenza virus including considerations for vaccine composition for (H5) vaccines, among other topics.
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October 16, 2024: Advancing Rare Disease Therapies Through an FDA Rare Disease Innovation Hub (Silver Spring, MD or virtual)
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October 24, 2024: FDA’s Total Product Life Cycle Approach to In Vitro Diagnostic Products (IVDs) (webcast)
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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.
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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.
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November 7, 2024: 16th Annual Sentinel Initiative Public Workshop (Washington, DC or virtual)
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Information for Industry and Health Care Providers
 In a recent webinar, clinicians heard directly from the FDA and CDC about the latest on the respiratory virus vaccine and therapeutic approval processes, medical products currently available, recommendations, and resources. View the recording (1 hour, 5 minutes) and subscribe to receive invitations to future events.
Gilead Issues Voluntary Nationwide Recall of One Lot of Veklury (Remdesivir) for Injection 100 mg/vial Due to the Presence of a Glass Particle
Gilead Sciences, Inc. is issuing a voluntary recall of one lot of Veklury (remdesivir) for Injection 100 mg/vial, to the consumer level. Gilead received a customer complaint and confirmed the presence of a glass particle in the vial during the company's investigation. (September 23, 2024)
Final Guidance: Conducting Clinical Trials With Decentralized Elements
This guidance provides recommendations for sponsors, investigators, and other interested parties regarding the implementation of decentralized elements in clinical trials. In this guidance, a decentralized clinical trial refers to a clinical trial that includes decentralized elements where trial-related activities occur at locations other than traditional clinical trial sites.
Guidance: Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice
As part of FDA’s Real-World Evidence (RWE) Program, this draft guidance is intended to support the conduct of randomized controlled drug trials with streamlined protocols and procedures that focus on essential data collection, allowing integration of research into routine clinical practice. Submit comments by December 17, 2024.
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In Case You Missed It
Quick COVID-19 Resources
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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.
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FDA in Your Day
Learn about how the FDA's work impacts you in this series of short videos featuring FDA leadership.
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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.
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Thanks for reading. This newsletter is produced by the FDA Office of Public Health Preparedness and Response, in the Office of the Chief Medical Officer (OCMO).
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