Purdue asks FDA to place restrictions on applications for follow-on versions of its Butrans transdermal patch system.
Attorney Kurt Karst says the FDA Office of Generic Drugs will have to adjust ANDAs that have been submitted for fixed-dose combination drugs that are ...
FDA associate commissioner Mary Lou Valdez says drug companies and regulators are working with the FDA India Office to improve quality and compliance....
MIT researchers say they have found a way to block a molecule and prevent implant-induced fibrosis from occurring.
FDA approves a Regeneron Pharmaceuticals NDA for Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema.
NDA Group says that NDA approvals were down in the U.S. in 2016 but remained level in the European Union.
FDA warns Singapores Opto-Pharm about CGMP and other violations in its manufacturing of finished pharmaceuticals.
Companies recommend that FDA decide between site and product reporting in a draft guidance on quality metrics.