[ Price : $8.95]
AdvaMed suggests changes to an FDA draft guidance on delaying, denying, limiting, or refusing a drug or device inspection.[ Price : $8.95]
A joint FDA advisory committee meeting votes to recommend the nonprescription use of Emergent BioSolutions Narcan (naloxone HCl) n...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection revision entitled Medical Device Labeling Requirements; Unique...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Considerations for Long-Term Clinical Neurodevelopmental Sa...[ Price : $8.95]
FDA issues Soligenix a refuse-to-file letter for its HyBryte (synthetic hypericin) NDA that is seeking an indication for treating ...[ Price : $8.95]
FDA warns Tuzia/Istanbul, Turkey-based Delta Kozmetik about CGMP violations in its production of finished drugs.[ Price : $8.95]
FDA warns Katy, TX-based Wintech Medipro about multiple violations in its manufacturing and distribution of unapproved surgical ma...[ Price : $8.95]
Eleven Republican members of Congress ask FDA and other agencies to respond to disputed claims that FDA drug reviewers take it eas...