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Federal Register notice: FDA makes available a draft guidance entitled Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported ...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.
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances on the design of bioequivalence studies to ...
FDA approves an Innocoll Holdings Limited NDA for Xaracoll (bupivacaine hydrochloride) for acute postsurgical pain relief for up to 24 hours in adults...