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Welcome to FDAweb Pay Per View Search our 45,659 - story database FREE   Free Items  Warning Letters  FDA Notices  FDA Calendar    FDA Whistleblowers            1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Next >>   FDA Clears Oramed IND for Oral Insulin Capsule [78 Words] [ Price : $7.95] FDA clears an Oramed Pharmaceuticals IND for ORMD-0801, an oral insulin capsule, indicated for the early stages of Type 2 diabetes. 05/17/2013     FDA OKs Direct Flow IDE for Transcatheter Aortic Heart Valve System [122 Words] [ Price : $7.95] FDA approves a Direct Flow Medical IDE to begin the SALUS feasibility trial of its Transcatheter Aortic Heart Valve System. 05/17/2013     Impax Launches Zomig Authorized Generic [63 Words] [ Price : $7.95] Impax Laboratories launches an authorized generic of AstraZeneca’s Zomig (zolmitriptan) tablets and orally disintegrating tablets. 05/17/2013     Thoratec HeartMate Pocket Controller Approved [123 Words] [ Price : $7.95] Thoratec gains FDA approval to market the HeartMate I Pocket Controller for the HeartMate II Left Ventricular Assist Device (LVAD) System. 05/17/2013     Guidance on CDRH Appeals Process [86 Words] [ Price : $7.95] Federal Register Notice: FDA releases a guidance describing the CDRH appeals processes. 05/17/2013     Panel to Discuss Moxduo Opioid Drug Combo [107 Words] [ Price : $7.95] Federal Register Notice: FDA’s Anesthetic and Analgesic Drug Products Advisory Committee will meet 7/17 to discuss QrxPharma’s NDA for Moxduo capsules for managing moderate to severe pain. 05/17/2013     FDA Approves Mylan’s Generic Tricor [107 Words] [ Price : $7.95] FDA approves a Mylan ANDA for fenofibrate tablets, 48 mg and 145 mg, a generic version of Abbvie’s Tricor tablets. 05/17/2013     Companies Seek Changes to Post-approval Modifications Guidance [498 Words] [ Price : $7.95] Companies urge FDA to make changes to its draft guidance on “Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA.” 05/17/2013     Pentec Recalls Compounded Therapies Due to Sterility Concerns [153 Words] [ Price : $7.95] Pentec Health recalls its in-date nutritional prescriptions for renal patients due to lack of sterility assurance associated with one of its laminar flow hoods used in compounding. 05/17/2013       1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20  Next >>

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