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Welcome to FDAweb Pay Per View Search our 62,850 - 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 >>   2 Guidances to Help Modernize Clinical Trials [565 Words] [ Price : $8.95] As part of its continuing push to modernize clinical trials, FDA posts two guidance documents to provide greater clarity and recommendation for drug developers. 10/15/2018     PhRMA DTC Pricing Effort Aims to Stave Off Regulations [411 Words] [ Price : $8.95] Presumably to avert new FDA regulations about adding price information in direct-to-consumer ads, Pharmaceutical Research and Manufacturers of America modifies its existing voluntary DTC principles to require member companies to include ways to find such information in their television ads. 10/15/2018     FDA Draft Guide on Rare Disease Pre-IND Meetings [65 Words] [ Price : $8.95] Federal Register notice: FDA makes available a draft guidance entitled “Rare Diseases: Early Drug Development and the Role of Pre-Investigational New Drug Application Meetings.” 10/15/2018     Class 1 Recall for Endologicx Endovascular AAA Device [199 Words] [ Price : $8.95] FDA classifies as a Class 1 recall an Endologix safety notice to healthcare professionals about its AFX Endovascular AAA [abdominal aortic aneurysm] System and the risks associated with Type III endoleaks. 10/15/2018     Civco Radiotherapy for Immobilization System [71 Words] [ Price : $8.95] FDA clears a Civco Radiotherapy 510(k) for its Solstice SRS Immobilization System. 10/15/2018     Untitled Letter on Web Site Product Promotion [167 Words] [ Price : $8.95] CBER sends an untitled letter to the operator of two Web sites — http://www.ollereg.com and http://www.innovativeallergy.com — because they were promoting an unapproved product, Ollereg Oral Immunotherapy. 10/15/2018     FDA Approves EyePoint Pharma Uveitis Drug [116 Words] [ Price : $8.95] FDA approves EyePoint Pharmaceuticals’ Yutiq (fluocinolone acetonide intravitreal implant) for treating chronic non-infectious uveitis affecting the posterior segment of the eye. 10/15/2018     Guide on Revised ‘Common Rule’ Implications [175 Words] [ Price : $8.95] FDA posts a guidance entitled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.” 10/12/2018     Notice on Pathogen Reduction Workshop Corrected [81 Words] [ Price : $8.95] Federal Register notice: FDA corrects a 9/17 notice announcing an 11/29 public workshop entitled “Pathogen Reduction Technologies for Blood Safety.” 10/12/2018     Grifols Test OK’d for Blood Group Genotyping [107 Words] [ Price : $8.95] FDA approves Grifols’ ID Core XT molecular diagnostic test for blood group genotyping. 10/12/2018       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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