FDA News Release
FDA Roundup: May 23, 2023
- For Immediate Release:
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- On Monday, the FDA and the Veterans Health Administration announced a new collaboration to jointly develop emergency preparedness and response tools and protocols intended to help increase medical product manufacturing capacity and flexibility, and improve resilience of domestic supply chains during emergencies, shortages, and pandemics. A new Memorandum of Understanding will help facilitate the development of requirements for trusted networks needed to enable the use of distributed manufacturing and digital stockpiles, which could ultimately enable veterans and civilians to more rapidly access innovative medical products to support their care. Learn more on FDA’s website, including descriptions of these advanced manufacturing approaches.
- On Monday, the FDA’s Center for Drug Evaluation and Research published two Guidance Snapshots accompanied by two Guidance Recap Podcasts to highlight the agency’s commitment to improve the diversity of participants in clinical trials, and to increase awareness of the agency’s 2020 guidance, Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs, which presents recommendations sponsors can apply to diversify participation in clinical trials. One snapshot-podcast set is for industry, and the other set is for patient communities. Guidance Snapshots and Recap Podcasts are an opportunity for FDA to present the recommendations in guidance documents in an innovative and often more audience-friendly manner, thereby increasing awareness of the agency’s recommendations among a broader group of people. The FDA is committed to promoting the diversity of participants in clinical trials that test the safety and effectiveness of new treatments.
- On Friday, the FDA approved Artivion, Inc.’s PerClot Polysaccharide Hemostatic System (PerClot system) intended to help to control bleeding that can occur during surgical procedures when other conventional approaches for controlling bleeding are ineffective or impractical. The PerClot system is composed of an applicator tip and absorbable polysaccharide granules that have a molecular structure that rapidly absorbs water, forming a gelled adhesive matrix that provides a mechanical barrier against bleeding. The plant-based, polysaccharide granules are not intended for use in neurological or ophthalmic surgical procedures.
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.
- FDA Office of Media Affairs