FDA generic drug researchers say modeling can shorten development time for generic drug-device combination drugs.
FDA warns Koreas Celltrion about CGMP violations in its production of finished pharmaceuticals.
FDA warns Taiwans Polaroison International about CGMP violations in its production of finished pharmaceuticals.
FDA announces a 4/24 public workshop on the current status of the regulatory science initiatives for generic drugs.
FDA chooses Octo Consulting for a seven-year contract to modernize and streamline the drug and medical device approval process as required by the 21st...
Two stakeholders recommend changes to an FDA draft guidance on clinical decision support software.
FDA commissioner Scott Gottlieb says agency scientists have found new data confirming opioid properties and 44 deaths reported from use of abusable bo...
A CDER small business podcast says generic drug manufacturers can find ANDA submission help in a recent guidance aiming to reduce the number of review...