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Welcome to FDAweb Pay Per View Search our 45,667 - story database FREE   Free Items  Warning Letters  FDA Notices  FDA Calendar    FDA Whistleblowers          << Prev  1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Next >>   FDA Approves Simponi for Ulcerative Colitis [55 Words] [ Price : $7.95] FDA approves Janssen’s Simponi for treating ulcerative colitis in adults. 05/15/2013     FDA Speeds Approval of Bayer’s Prostate Cancer Drug [337 Words] [ Price : $7.95] Three months ahead of its user fee review schedule, FDA approves a Bayer Pharmaceuticals NDA for Xofigo to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones. 05/15/2013     Appeals Court Grants Temporary Stay on Plan B [220 Words] [ Price : $7.95] The Second Circuit Court of Appeals grants FDA a temporary stay of a federal judge’s order requiring the agency to approve levonorgestrel-based emergency contraceptive drugs for nonprescription sale without age restrictions. 05/14/2013     FDA Approves Arbor Pharma’s Nymaliz [181 Words] [ Price : $7.95] FDA approves an Arbor Pharmaceuticals NDA for Nymaliz (nimodipine) oral solution, indicated for improving neurological outcome in adult patients with subarachnoid hemorrhage. 05/14/2013     FDA Priority Review for Janssen Hepatitis C Drug [169 Words] [ Price : $7.95] FDA grants Janssen a priority review for its NDA for simeprevir (TMC435), an investigational NS3/4A protease inhibitor for treating genotype 1 chronic hepatitis C in adult patients with compensated liver disease. 05/14/2013     Info on DTC Advertising Sent to OMB [47 Words] [ Price : $7.95] Federal Register Notice: FDA submits a proposed collection of information on communicating composite scores in direct-to-consumer advertising. 05/14/2013     Guidance on Pharmacoepidemiologic Safety Studies [93 Words] [ Price : $7.95] Federal Register Notice: FDA releases a guidance, Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data. 05/14/2013     DSOB Looks at Drug Info for Population Subgroups [137 Words] [ Price : $7.95] FDA’s Drug Safety Oversight Board discusses a requirement that the agency review and modify communication plans on drug benefits and risks. 05/14/2013     FDA Accepts Invacare Consent Decree Audit [512 Words] [ Price : $7.95] FDA finds acceptable Invacare’s first certification audit under its recent consent decree relating to the qualification and validation documentation for equipment and processes at its Taylor St. manufacturing facility in Elyria, OH. 05/14/2013     510(k) Program is ‘Sound and Well Worth Reforming’: Attorney [307 Words] [ Price : $7.95] Attorney Jeffrey Shapiro praises the current operation of the 510(k) substantial equivalence program and suggests a way to make it more transparent. 05/14/2013     << Prev  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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