FDA accepts an IND for a PharmaTher Phase 2 trial of ketamine to treat ALS.
Federal Register notice: FDA issues a final rule to revoke the regulations for human tissue intended for transplantation and human dura mater recovere...
Federal Register notice: FDA issues a final rule to amend the medical device regulations on procedures for announcing approvals and denials of PMAs an...
FDA clears an Abbott 510(k) for the EnSite EP System with EnSite Omnipolar Technology, a new cardiac mapping platform designed to help physicians bett...
FDA releases an FDA-483 with seven observations from an inspection at Longview, TX-based Med Shop Total Care.
Federal Register notice: FDA corrects a notice in the 11/1/2021 Federal Register that announced the regulatory review period for Daiichi Sankyos Enher...
FDA warns against using unapproved LuSys Laboratories Covid-19 tests due to a potentially high risk of false results.
FDA and the Duke-Margolis Center for Health Policy publish a summary of a 2019 workshop they co-sponsored on improving the communication of drug inter...