Federal Register notice: FDA announces an 11/4 regional public meeting between Health Canada and FDA on the International Council for Harmonization ph...
CDRH issues lists of final and draft guidances it expects to publish in FY 2020.
The Federal Trade Commission says a Florida federal court has approved a settlement with Nature City over the companys false and unsubstantiated healt...
FDA cautions against use of cannabis products by women who are pregnant or breastfeeding.
Pennsylvania attorney general Josh Shapiro says Johnson & Johnson and its Ethicon subsidiary have settled allegations of deceptive marketing of transv...
FDA accepts for review a Foamix Pharmaceuticals NDA for FMX103 (minocycline topical foam 1.5%) topical foam for treating moderate-to-severe papulopust...
FDA approves a Genentech supplemental NDA for Xofluza (baloxavir marboxil) for treating acute, uncomplicated influenza in people 12 years of age and o...
Viatrexx Bio recalls all products in 10 mL sterile injectable vials because they were manufactured in a manner that cannot guarantee their sterility.