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Welcome to FDAweb Pay Per View Search our 45,668 - 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 >>   Virology Studies Assay Guidance Sought [225 Words] [ Price : $7.95] Lack of available assays can hurt development of new antiviral drugs, companies say in responding to draft FDA guidance. 05/14/2013     Don’t Drive Day After Using Ambien CR: FDA [119 Words] [ Price : $7.95] FDA says updated labeling for Ambien CR includes a warning against next-day driving. 05/14/2013     Safety Study Guidance Out [140 Words] [ Price : $7.95] FDA publishes a guidance with best practices for conducting and reporting on pharmacoepidemiologic safety studies using electronic healthcare data. 05/14/2013     OMB OKs Info on Rx Drug Med Guide Requirements [43 Words] [ Price : $7.95] Federal Register Notice: The Office of Management and Budget approves a collection of information on prescription drug medication guide requirements. 05/14/2013     FDA Approves Tarceva Companion Assay [103 Words] [ Price : $7.95] FDA approves a Roche diagnostic companion test for Genentech’s Tarceva as part of an expanded Tarceva indication. 05/14/2013     41 State Attorneys General Want Neonatal Warning on Opioids [178 Words] [ Price : $7.95] Forty-one state attorneys general urge FDA to place a black box warning on opioid analgesics to indicate the risk of Neonatal Abstinence Syndrome. 05/14/2013     C.R. Bard Agrees to Pay $48 Million Over Illegal Kickbacks [168 Words] [ Price : $7.95] C.R. Bard agrees to pay the government $48.26 million to resolve claims that it knowingly caused false claims to be submitted to the Medicare program for brachytherapy seeds used in treating prostate cancer. 05/14/2013     FDA Sends Info on NADA Presubmission Conferences to OMB [64 Words] [ Price : $7.95] Federal Register Notice: FDA submits a proposed collection of information on presubmission conferences for NADAs to the Office of Management and Budget. 05/13/2013     Rev-Eyes Not Withdrawn for S&E [59 Words] [ Price : $7.95] Federal Register Notice: FDA determines that Rev-Eyes, 0.5% was not withdrawn from sale for reasons of safety or effectiveness. 05/13/2013     Panel to Discuss Endosseous Dental Implant Reclassification [87 Words] [ Price : $7.95] Federal Register Notice: FDA’s Dental Products Panel will meet 7/18 to discuss regulatory classification for endosseous dental implants (blade-form). 05/13/2013     << 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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