Pediatric Tracking Requirements Under FDAAA
The Food and Drug Administration Amendments Act (FDAAA) requires that the FDA track and make publicly available certain pediatric information resulting from pediatric clinical trials pursuant to FDAAA. In accordance with section 505A (Best Pharmaceuticals for Children...Medline Removes Certain Convenience Kits Due to Lack of Sterilization
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.Affected ProductLRO – Sterile Medline Convenience...Executive Order 14017 America’s Supply Chains
Image IntroductionKeeping U.S. medical product and food supply chains secure, robust, and resilient is essential for the health and national security, and economic prosperity of the United States, including during emergencies like the COVID-19 pandemic. As part of...Drug Trials Snapshots: MODEYSO
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For Immediate Release: November 19, 2025 The U.S. Food and Drug Administration today announced a pilot program designed to streamline communications with sponsors following formal meetings. Through the program, sponsors are given a “Meeting Minute Clarification...All Drug Purchases Are
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