CDRHs Malvina Eydelman touts the early successes of the new Breakthrough Device Program created under the 21st Century Cures Act.
Federal Register notice: FDA announces a 3/29-30 Clinical Chemistry and Clinical Toxicology Devices Panel meeting.
FDA posts an International Council for Harmonization guidance on E6 (R2) Good Clinical Practice: Integrated Addendum to ICH E6 (R1) that provides a un...
FDA issues Celgene a refusal-to-file letter on an NDA for ozanimod for treating patients with relapsing forms of multiple sclerosis.
Federal Register notice: FDA submits for OMB approval an information collection extension for Guidance for Industry, Researchers, Patient Groups, and ...
Attorney Kurt Karst highlights skyrocketing FDA orphan drug designations requests and approvals.
A Tennessee federal court jury convicts the former president of Cumberland Distribution in a large drug diversion scheme.
The Office of Pharmaceutical Quality 2017 annual report outlines challenges and key quality initiatives addressed last year.