FDA Roundup: October 6, 2023

SILVER SPRING, Md., Oct. 6, 2023 /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 updated its infant formula compliance program for FDA investigators, laboratory analysts, and compliance officers. The compliance program is designed to comprehensively outline the agency’s approach for inspections, sample collection, sample analysis, and compliance activities to help ensure that infant formula products in the U.S. food supply are safe and nutritious. This effort is part of the FDA’s ongoing commitment to strengthen the safety, resiliency, and oversight of the infant formula industry.
On Thursday, the FDA provided an update on the recalled Philips ventilators, BiPAP machines, and CPAP machines associated with the breakdown of PE-PUR foam. The FDA remains steadfast in our commitment that patients impacted by the recall deserve relief. While this matter is ongoing, the agency continues to monitor the company’s recall progress and share new information with device users, patient care facilities, and other stakeholders. The FDA remains unsatisfied with the status of this recall, and we continue to take steps to protect the health and safety of individuals using these devices.

As part of our continued efforts to ensure consumers have the latest information on the Philips recall, the FDA published a new resource section on FDA.gov, including a comprehensive timeline of FDA activities related to the June 2021 recall. Patients, consumers, and health care providers have played an integral part in providing feedback to the FDA about the Philips’ recall, and their feedback is reflected in this new resource to ensure it provides timely and accurate information.
On Wednesday, the FDA authorized marketing of the Marizyme, Inc.’s DuraGraft Vascular Conduit Solution, which is intended for flushing and short-term storage of saphenous vein grafts (either of the two chiefly superficial veins of the leg) from harvesting through grafting for adult patients undergoing coronary artery bypass grafting surgeries. The DuraGraft device is the first solution that is specifically labeled for this use.
On Tuesday, the FDA announced the signing of a partnership agreement with the Pennsylvania Department of Agriculture’s Bureau of Food Safety & Laboratory Services that will focus on inventory reconciliation, reducing foodborne illness risk, and minimizing duplication of work. Through such partnerships, FDA works with states with comparable regulatory public health systems, as trusted partners, to rely on, coordinate with, and leverage one another’s work, data, and actions to meet the public health goal of a safe national food supply.
The FDA’s Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance program is hosting its 2023 NanoDay Symposium: Continuous Manufacturing of Nanomaterials on October 11. The symposium is open to the public and will provide an overview of CDER experience with approving several solid oral drug products which benefited from the continuous manufacturing technologies. The symposium will also feature case-studies of intramural and extramural research in the areas of nanomaterials and continuous manufacturing, to further encourage the innovation and adoption of continuous manufacturing. Register online.

Additional Resources:

FDA Newsroom

Media Contact: FDA Office of Media Affairs, 301-796-4540

Consumer Inquiries: 888-INFO-FDA

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, products that give off electronic radiation, and for regulating tobacco products.