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Welcome to FDAweb Pay Per View Search our 45,601 - story database FREE   Free Items  Warning Letters  FDA Notices  FDA Calendar    FDA Whistleblowers          << Prev  4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 Next >>   FDA Accepts Octapharma BLA for Octaplex [139 Words] [ Price : $7.95] FDA accepts for review an Octapharma BLA for Octaplex, indicated for reversing anticoagulation therapy in patients undergoing vitamin K antagonist therapy with the need for urgent surgery or invasive procedures. 04/29/2013     House Hearing Dismisses FDA Request for New User Fees [650 Words] [ Price : $7.95] House budget subcommittee chair Robert Aderholt (R-AL) tells FDA commissioner Margaret Hamburg that new proposed user fees for inspections as part of the FY 2014 budget request are “not authorized, and the chance of Congress authorizing them seems slim.” 04/29/2013     FDA Approves CSL Behring’s Anticoagulation Complex [240 Words] [ Price : $7.95] FDA approves CSL Behring’s Kcentra (prothrombin complex concentrate, human) for the urgent reversal of vitamin K antagonist anticoagulation in adults with acute major bleeding. 04/29/2013     FDA Safety Alert on GSK’s Potiga [240 Words] [ Price : $7.95] A new FDA drug safety alert says GlaxoSmithKline’s anti-seizure drug Potiga (ezogabine) can cause blue skin discoloration and eye abnormalities. 04/29/2013     Justice Dept. Sues Novartis Again on False Claims [403 Words] [ Price : $7.95] The Justice Department files a second civil false claims lawsuit against Novartis for alleged illegal kickbacks paid to health care providers. 04/29/2013     FDA Says No to Generic HalfLytely Due to Ischemic Colitis [205 Words] [ Price : $7.95] Citing ischemic colitis concerns, FDA denies a petition to allow ANDAs for generic copies of Braintree’s HalfLytely (10 mg bisacodyl) Bowel Prep Kit product. 04/29/2013     Appeals Court Rules for FDA in Seroquel Exclusivity Case [249 Words] [ Price : $7.95] An appeals court rules in FDA’s favor and affirms a lower court decision that gave deference to the agency when it decided that a supplemental NDA for AstraZeneca’s was not entitled to any additional marketing exclusivity. 04/29/2013     Blockade Medical Gains Clearance for Barricade Coil System [81 Words] [ Price : $7.95] FDA clears a Blockade Medical 510(k) for the Barricade Coil System for treating a variety of morphologies. 04/29/2013     CDRH Mulls Changes to 510(k) Modifications Process [314 Words] [ Price : $7.95] As part of CDRH’s 510(k) revamp initiative, the Center moves attention to device modifications and when these require new 510(k)s. 04/26/2013     FDA Clears NinePoint’s NvisionVLE for Esophageal Imaging [75 Words] [ Price : $7.95] FDA grants 510(k) clearance to NinePoint Medical for its Nvision VLE Imaging System for esophageal tissue microstructure. 04/26/2013     << Prev  4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23  Next >>

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