Unapproved New Drugs/Misbranded
Similar Posts
GDUFA Implementation Quarterly Meetings between FDA and Industry
FDA and representatives of the generic drug industry meet quarterly to discuss topics related to the implementation of GDUFA.Drug Development Considerations for the Treatment of Neonatal Enterovirus Infection and Congenital Cytomegalovirus Infection–Virtual Public Workshop – 05/07/2024
The Food and Drug Administration is holding a public, two-day workshop entitled Development of Drugs for the Treatment of Congenital Cytomegalovirus (CMV) Infection and Neonatal Enterovirus Infection.Wholesale Produce Supply of Minneapolis, Minnesota is Recalling Fresh Cut/Processed Cantaloupe, Because it has the Potential to be Contaminated With Listeria Monocytogenes
Wholesale Produce Supply of Minneapolis, Minnesota is Recalling Fresh Cut/Processed Cantaloupe, Because it has the Potential to be Contaminated With Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others withInvestigational New Drug (IND) Application
Get to know the investigational new drug application (IND). This includes the types, laws and regulations, and emergency use of INDs.Cranial Drill Recall: Integra LifeSciences Recalls Codman Disposable Perforators Due to Risk of Device Disassembly
Certain Codman Disposable Perforators may disassemble during or after use, increasing the risk of brain injury, hemorrhage, or prolonged surgery.Resources for Biomarker Requestors
Information and resources for requestors about FDA’s Biomarker Qualification Program