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Welcome to FDAweb Pay Per View Search our 63,616 - 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 Priority Review for Merck Keytruda sBLA [226 Words] [ Price : $8.95] FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), its anti-PD-1 therapy as monotherapy or in combination with platinum and 5-fluorouracil chemotherapy for the first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma. 02/11/2019     Regulatory Review Period for Sarepta’s Duchenne Drug [67 Words] [ Price : $8.95] Federal Register notice: FDA has determined that the regulatory review period for Sarepta’s Duchenne drug Exondys 51 (eteplirsen). 02/11/2019     New Efforts Mulled to Modernize Dietary Supplement Regulation [503 Words] [ Price : $8.95] FDA says it is working on a new plan to modernize dietary supplement regulation and oversight. 02/11/2019     OCI Lends Support in Drug Compounding Kickback Scheme [172 Words] [ Price : $8.95] FDA’s Office of Criminal Investigations helps investigate a case where a Texas marketer agreed to pay the government $339,413 for allegedly accepting illegal kickback payments from OK Compounding. 02/11/2019     Workshop on Boosting Patient Perspectives on Clinical Trials [99 Words] [ Price : $8.95] Federal Register notice: FDA announces a 3/18 workshop entitled “Enhancing the Incorporation of Patient Perspectives on Clinical Trials,” which is being convened by the ongoing Clinical Trials Transformation Initiative. 02/11/2019     ANDA Summary Tables Updated [154 Words] [ Price : $8.95] FDA updates summary table forms for ANDA submissions containing clinical endpoint studies. 02/11/2019     BioDirection Gains Breakthrough Designation for Tbit System [142 Words] [ Price : $8.95] FDA grants BioDirection a breakthrough device designation for its Tbit System for the prediction of positive computerized tomography scans following a traumatic brain injury. 02/11/2019     FDA Targets 17 Online Unapproved Product Marketers [111 Words] [ Price : $8.95] FDA issues 12 Warning Letters and 5 online advisory letters to companies that are “illegally” selling more than 58 products that are unapproved or misbranded drugs. 02/11/2019     Orphan Designation for APX001 Treating Cryptococcosis [256 Words] [ Price : $8.95] FDA grants Amplyx Pharmaceuticals an orphan drug designation for APX001 and its use for treating cryptococcosis. 02/11/2019     Latest Federal Register Notices [1379 Words] [ Price : $8.95] FDA Review posts the Federal Register notice for the week ending 2/8/2019. 02/10/2019       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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