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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Federal Register notice: FDA has made available a draft guidance entitled Content of Premarket Submissions for Management of Cyber...[ Price : $8.95]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.[ Price : $8.95]
Federal Register notice: FDA seeks comments on a new proposed research study entitled Experimental Study of an Accelerated Approva...[ Price : $8.95]
Federal Register notice: FDA seeks public comments on a proposed research study entitled, Disease Awareness and Prescription Drug ...[ Price : $8.95]
Federal Register notice: FDA classifies the external upper limb tremor stimulator into Class 2 (special controls).[ Price : $8.95]
Teva asks a federal court to order 180-day exclusivity for its Restasis ANDA.