FDA Roundup: August 9, 2024

SILVER SPRING, Md., Aug. 9, 2024 /PRNewswire/ — Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

Today, the FDA invites the public to register for the public meeting on the Development of an Enhanced Systematic Process for the FDA’s Post-Market Assessment of Chemicals in Food, which will be held on September 25, 2024, from 12:30-4:30 p.m. ET. The purpose of this meeting is for FDA to share information about the development of FDA’s enhanced systematic process for post-market assessment of chemicals in food, including considerations for identifying and prioritizing food chemicals currently in the market for safety reviews. In addition, industry and consumer advocacy experts, government officials, research organizations, and other stakeholders will have the opportunity to learn more, ask questions, and provide open public comment to address specific questions posed by the FDA. This information will help inform our further development of the process. This project is part of a larger enhanced approach for food chemical safety. For additional information about the meeting, including how to request to make open public comments, please visit the Federal Register Notice.
On Thursday, the FDA released a set of documents regarding the transition phase after the agency’s longstanding Memorandum of Understanding with the Association of American Feed Control Officials (AAFCO) expires on October 1, 2024. The documents include a request for public comments on the FDA’s existing pre-market animal food ingredient review programs, Draft Guidance for Industry #293, FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients, and Draft Guidance for Industry #294, Animal Food Ingredient Consultation (AFIC). The FDA is accepting public comments on the two draft guidances until September 9, 2024, and on the request for comments until December 9, 2024.
On Thursday, the FDA released its updated 2024 Language Access Plan, taking another key step toward addressing language barriers that impact health equity and strengthening language access to health information and services for the public, including people with Limited English Proficiency and people with disabilities. The plan also supports FDA efforts to identify interpretation language assistance, translate, and make important documents accessible, as well as digital and web content into multiple languages. The Language Access Program, led by the FDA’s Office of Minority Health and Health Equity, is a part of the FDA’s ongoing work to help individuals make informed decisions about their health.
On Thursday, the FDA granted an emergency use authorization to Octapharma Pharmazeutika Produktionsges.m.b.H. for emergency use of octaplasLG Powder (blood group types A and AB) for U.S. military forces for the treatment of hemorrhage or coagulopathy during an emergency involving agents of military combat (e.g., firearms, projectiles, and explosive devices) when plasma is not available for use or when the use of plasma is not practical.

Hemorrhage, sometimes accompanied by coagulopathy (a condition that affects the blood’s ability to clot), is a leading cause of death among combat trauma casualties. Plasma contains proteins that may be effective at helping clot blood and can be used for the management of hemorrhage and coagulopathy. However, its use in combat settings is severely limited by logistical and operational challenges such as the need for refrigeration and, in the case of frozen plasma, a long thawing period.

OctaPlasLG Powder is a powdered freeze-dried product that can be used following reconstitution (adding water back to the powder) in settings where refrigeration is not available, thus enabling the rapid availability of plasma for use at the point of injury. Information is available on FDA’s website.
On Wednesday, the FDA updated the list of Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices. With this update, the FDA has authorized 950 AI/ML-enabled medical devices. The devices in this list have met the FDA’s applicable premarket requirements, including a focused review of the devices’ overall safety and effectiveness, which includes an evaluation of appropriate study diversity based on the device’s intended use and technological characteristics.
On Tuesday, the FDA published a blog titled FDA India Office Addresses Herbal and Ayurvedic Products. This latest in the FDA’s “From A Global Perspective” series and discusses the FDA’s take on the regulatory issues surrounding India’s Ayurvedic and Herbal exports, many of which are based on centuries-old traditional medicine.

Additional Resources:

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.