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Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Regeneron Pharmaceu...[ Price : $8.95]
Federal Register notices: FDA makes available six medical device classification orders.[ Price : $8.95]
FDA approves Abbotts HeartMate 3 Left Ventricular Assist Device as a destination therapy for people living with advanced heart fai...[ Price : $8.95]
FDA issues Ocular Therapeutix a 10/17 Warning Letter over the companys compliance with data collection and information reporting o...[ Price : $8.95]
Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Genentechs Ocrevus ...[ Price : $8.95]
A Bloomberg Law online post explores differing views on the legality and effectiveness of an HHS proposal to require drug companie...[ Price : $8.95]
Federal Register notice: FDA has made available a draft guidance entitled Content of Premarket Submissions for Management of Cyber...[ Price : $8.95]
A CDRH Webinar reviews the 510(k) Quik pilot program requirements and operation.