FDA releases the summary of an Ophthalmic Devices Panel meeting that recommended against approving the Refocus Groups VisAbility Micro Insert System.
FDA says a Cook Medical recall of its fixed core wire guides is Class 1.
The Washington Post suggests FDA commissioner Stephen Hahns job hangs in the balance due to president Trumps anger over promising Covid-19 vaccine dat...
FDA issues a MAPP on responsibilities and procedures for the CDER controlled substances staff to review and comment on DEA research protocols using Sc...
A University of Pennsylvania Law School regulatory analysis examines a Council on Foreign Relations working paper critiquing the new FDA drug importat...
The Informed Consent Action Network asks FDA to order changes to the Phase 3 trial protocols for four Covid-19 vaccines that it says will demonstrate ...
FDA commissioner Stephen Hahn says the agency is meeting many of its FY 2020 goals in addition to all of its Covid-19 work.
Beyond Air says it submitted a PMA application to FDA for its LungFit PH to treat persistent pulmonary hypertension of the newborn.