FDA warns South Koreas Hanlim Pharma about CGMP violations in its manufacturing of finished pharmaceuticals.
CDERs Office of Prescription Drug Promotion says a Facebook post about MannKinds Afrezza misbrands the drug by failing to adequately discuss its serio...
Federal Register notice: FDA makes available a draft guidance entitled Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual...
Federal Register notice: FDA makes available a final guidance entitled Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease....
FDA warns California doctor Ignatius Godoy about violations in his role as clinical investigator in a pediatric flu vaccine study.
CDRH participates in a Kidney Health Initiative workgroup to explain regulatory considerations for central venous catheters for hemodialysis.
FDA asks for comments on proposed research looking at how consumers respond to disease awareness communications that accompany television direct-to-co...
FDA issues a draft guidance with recommendations for how companies can present quantitative efficacy and risk information in DTC human and animal drug...