FDA Roundup: April 12, 2024

SILVER SPRING, Md., April 12, 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Today, the FDA will reopen the comment period for 60 days for the draft guidance “Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination (DWPE) and Removal of a Foreign Manufacturer’s Goods from DWPE,” announced in the Federal Register on February 12, 2024.

On Thursday, the FDA announced several actions that have been taken to better understand the safety and effectiveness of surgical mesh mini-slings to treat female stress urinary incontinence (SUI) including evaluating the results of long-term follow up studies and completing an in-depth literature review to evaluate the performance of the mini-slings compared to the traditional mid-urethral slings. The results continue to support the FDA’s conclusion that mini-slings have comparable clinical performance to traditional mid-urethral slings through at least 36 months for treating female SUI. The FDA’s recommendations have not changed.

On Wednesday, the FDA provided an update on our ongoing evaluation of quality and performance issues related to plastic syringes made in China and announcing expanded actions for Jiangsu Shenli Medical Production Co. Ltd. with an additional import alert for not meeting device quality system requirements, to prevent all plastic syringes by this manufacturer from entering the U.S. Additionally, the recommendations in the safety communication have been updated.

On Tuesday, the FDA approved Pradalex (pradofloxacin injection) solution for certain respiratory diseases in cattle and swine. Pradofloxacin is a medically important antimicrobial in the fluoroquinolone class and may only be prescribed by a licensed veterinarian as a single injection.

On Tuesday, the FDA authorized marketing of the Rho sponsored by 16 Bit, Inc. The Rho is a software application that uses a machine learning algorithm to pre-screen patients 50 years of age and older who may have low bone mineral density (BMD) using existing radiographs of the lumbar spine, thoracic spine, chest, pelvis, knee or hand/wrist. The radiologists receive a Rho report for low BMD patients only. Clinicians should follow recommended practices for bone health assessment and possible screening regardless of the Rho report.

On April 1st, the FDA Office of Minority Health and Health Equity (OMHHE) kicked off the National Minority Health Month Celebration (NMHM). As part of the celebration, at 11:00 AM ET on April 17th OMHHE will host “Strategies to Increase Clinical Trial Participation for Diverse Communities, A Panel Discussion with the OMHHE REACH Consortium.” The virtual panel discussion will feature a keynote address from Principal Deputy Commissioner of the FDA, Dr. Namandjé N. Bumpus. Learn more about this event by visiting the FDA NMHM page.

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, radiation-emitting electronic products, and for regulating tobacco products.

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SOURCE U.S. Food and Drug Administration