FDA issues a guidance to help manufacturers prevent unacceptable levels of nitrosamines in all chemically synthesized drugs.
Scripps Research Translational Institute director Eric Topol writes an open letter to FDA commissioner Stephen Hahn asking him to hold a press confere...
Twenty-three attorneys general ask FDA not to allow branded drug companies to list device and component patents in the Orange Book as a way to speed g...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Innate Pharmas Lumoxiti.
Federal Register notice: FDA seeks comments on an information collection extension for Adverse Experience Reporting For Licensed Biological Products; ...
FDA commissioner Stephen Hahn says it is possible that an emergency use authorization for a Covid-19 vaccine could be granted before Phase 3 clinical ...
Federal Register notice: FDA makes available a draft guidance entitled Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported ...
Federal Register notice: FDA publishes a list of information collections that have been approved by OMB.