Unapproved New Drug/Misbranded
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Qualified Clinical Outcome Assessments (COA)
The table below lists qualified Clinical Outcome Assessments (COA). The tables include legacy projects (those submitted prior to passage of the 21st Century Cures Act), as well as those submitted as part of the newer section 507 process (referring to section 507 of the Federal Food, Drug and CosmetiMedical Procedure Kits Correction: Medline Industries, LP Issues Correction for Medline Craniotomy Kits Containing Codman Disposable Perforators Due to Risk for Device Disassembly
Medline Craniotomy Kits are procedure convenience kits. Kits containing the Codman Disposable Perforator are being corrected by Medline Industries.Mr. Strong Guy Honey For Him contains hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use Mr. Strong Guy Honey For Him, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.What’s New Related to Drugs
Want to know what’s new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.Upcoming EL-PFDD Meetings
Upcoming EL-PFDD MeetingsMedtronic Announces Voluntary Recall of Select Newport™ HT70 and Newport™ HT70 Plus Ventilators and Certain Related Newport™ Service Parts
In May 2025, Medtronic issued a voluntary recall notification to global customers related to specific Newport™ HT70 and HT70 Plus ventilators and certain related Newport™ service parts. The FDA recently designated this voluntary action by Medtronic as a Class I recall.
With this recall, Medtronic i
