Two Morgan Lewis attorneys explore decisions facing FDA in light of an 11th Circuit Court of Appeals ruling on orphan drug exclusivity that FDA disagr...
AdvaMed suggests changes to an FDA draft guidance on delaying, denying, limiting, or refusing a drug or device inspection.
Federal Register notice: FDA sends to OMB an information collection revision entitled Medical Device Labeling Requirements; Unique Device Identificati...
Federal Register notice: FDA makes available a draft guidance entitled Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neon...
FDA issues Soligenix a refuse-to-file letter for its HyBryte (synthetic hypericin) NDA that is seeking an indication for treating early stage cutaneou...
FDA warns Tuzia/Istanbul, Turkey-based Delta Kozmetik about CGMP violations in its production of finished drugs.
FDA warns Katy, TX-based Wintech Medipro about multiple violations in its manufacturing and distribution of unapproved surgical masks.
Eleven Republican members of Congress ask FDA and other agencies to respond to disputed claims that FDA drug reviewers take it easy on companies for w...
