FDA Roundup: June 4, 2024

News provided by

Jun 04, 2024, 15:00 ET

SILVER SPRING, Md., June 4, 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 published When We Work Together, Hand in Glove with Our Partners, We Can Overcome Any Barrier: A Conversation with EMA's Emer Cooke. The interview is the latest in the FDA's blog series From a Global Perspective. These are occasional thought pieces on international topics from experts across the FDA and interviews with global public health leaders. The interview followed FDA Commissioner Robert Califf's trip to the European Medicines Agency in February and April's FDA-EU Bilateral in Washington.
On Monday, the FDA announced additional recalls initiated by Medline Industries LP, a firm marketing and distributing plastic syringes made in China within the U.S., to stop using affected products which include bulk unauthorized plastic syringes made in China and bulk plastic syringes made in China with performance testing failures. The FDA will continue efforts to evaluate problems with syringes made in China and keep the public informed as new or additional information becomes available.
On Wednesday, the FDA published 10 things to know about CDER's pharmaceutical quality functions. Pharmaceutical quality is about more than just the quality of the drug itself. It includes the manufacturing facilities and the processes used to manufacture the drug. Some of CDER's pharmaceutical quality functions occur before a prescription drug is approved and reaches patients. CDER also monitors drugs on the market and the facilities making them to ensure continued quality.
On Friday, the FDA issued a Safety Alert to warn parents and caregivers of Cronobacter safety concerns with Crecelac Infant Powdered Goat Milk Infant Formula imported and distributed by Dairy Manufacturers Inc. Although the company initiated a recall of several infant formula products on May 24, 2024, because they were not in compliance with all of the FDA's infant formula regulations, the FDA issued this safety alert due to new findings of Cronobacter contamination in a sample of Crecelac Infant Powdered Goat Milk Infant Formula.

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.

SOURCE U.S. Food and Drug Administration