FDA contracts with the University of Maryland Smith School of Business to research the possibility of increasing drug manufacturing in the U.S.
FDA issues a guidance with recommendations for documenting electronic data files and statistical analyses submitted to CVM to support new animal drug ...
FDA clears a SafKan Health 510(k) for its OtoSet Ear Cleaning System for removing impacted earwax.
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...