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Welcome to FDAweb Pay Per View Search our 45,901 - story database FREE   Free Items  Warning Letters  FDA Notices  FDA Calendar    FDA Whistleblowers          << Prev  21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 Next >>   Judge Korman Denies FDA Stay on Plan B Order [662 Words] [ Price : $7.95] U.S. District Judge Edward Korman denies an FDA request to stay his order last month that the agency lift age restrictions on all levonorgestrel-based emergency contraceptives. 05/10/2013     Pfizer Needs More Clinical Studies for Remoxy [146 Words] [ Price : $7.95] Pfizer says additional clinical studies are necessary before it can resubmit an NDA for Remoxy (oxycodone), a formulation of the common pain drug intended to discourage tampering. 05/10/2013     Comments Sought on Authorized Generic Drugs Reporting [43 Words] [ Price : $7.95] Federal Register Notice: FDA seeks comments on information collection related to reporting information about authorized generic drugs in an annual report. 05/10/2013     Panel to Discuss Organon NDA for Neuromuscular Blockade [101 Words] [ Price : $7.95] Federal Register Notice: FDA’s Anesthetic and Analgesic Drug Products Advisory Committee will meet 7/18 to discuss an Organon USA NDA for sugammadex sodium injection to treat neuromuscular blockade. 05/10/2013     FDA Denies Endo Petition on Crush-resistant Opana ER [136 Words] [ Price : $7.95] FDA denies a 2012 Endo Health Solutions citizen petition that sought to block generic copies of its Opana ER (oxymorphone HCl). 05/10/2013     Standard Approach Sought for Immunosuppressant NDAs [189 Words] [ Price : $7.95] The Skadden Arps law firm asks FDA to maintain a 12-month clinical trial standard for NDAs for new, modified, or reformulated primary or adjunctive immunosuppressants for kidney transplant patients. 05/09/2013     2 Draft Investigational Drug Guidances Out [137 Words] [ Price : $7.95] FDA releases draft guidances on expanded access to investigational drugs for treatment uses and charging for investigational drugs under an IND. 05/09/2013     Per Capita Spending on Medicines Down 3.5% [109 Words] [ Price : $7.95] An IMS report says total spending on U.S. medicines was $325.8 billion in 2012, down 3.5% from the previous year. 05/09/2013     Warner Chilcott New Contraceptive Approved [95 Words] [ Price : $7.95] FDA approves a Warner Chilcott NDA for its new oral contraceptive, norethindrone acetate and ethinyl estradiol chewable tablets and ferrous fumarate tablets. 05/09/2013     Former FDA Orphan Drug Head Joins Emmaus Medical [187 Words] [ Price : $7.95] Former FDA Office of Orphan Product Development director Timothy Cote joins Emmaus Medical to help the company on its regulatory pathway for the company's sickle cell disease treatment. 05/09/2013     << Prev  21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40  Next >>

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