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		search within: All Publications Medicare Drug Focus "The Blue Sheet" "The Gold Sheet" "The Gray Sheet" Medicare Guide "The Pink Sheet" "The Pink Sheet DAILY" "The Rose Sheet" "The Silver Sheet" "The Tan Sheet" Health News Daily Pharmaceutical Approvals Research Policy ALERT Washington Fax    June 30, 2008 Volume 70 , Number 26  Cymbalta Fibromyalgia Approval Sets Another REMS Precedent FDA’s approval of Lilly’s Cymbalta (duloxetine) for treatment of fibromyalgia sets another precedent in the new era of Risk Evaluation and Mitigation Strategies: the agency will not necessarily seek a formal REMS for products already accompanied by mandatory medication guides.   READ MORE>> New Faces Will Lead Office Of Regulatory Affairs As Two Top Officials Depart The face of FDA’s Office of Regulatory Affairs will undergo a major change as two senior leaders leave the office responsible for managing inspections and enforcement activity.   READ MORE>> Biogenerics Get A Low Score From CBO, But Is BIO Actually The Loser? The reaction of stakeholders to the Congressional Budget Office’s score of potential savings from follow-on biologics illustrates the challenges for the various players as debate on legislation continues.   READ MORE>>       Coventry Shifting Medicare PBM Duties To Medco From CVS Caremark     Part D’s Effect On Generic Statins; More ASHE In Brief     U.K. Drug Spending Plan Balances 5% Cut With Increased Access       Chart: FDA's ANDA Approvals       Roche Makes Early Headway With Pharmaco-Diagnostics       California E-Pedigree Phase-In Bill Moving Through State Legislature       Panel Endorses Samska, Infers Clinical Benefit For The Hyponatremia Drug     Breaking news from “The Pink Sheet” DAILY     Merck’s Gardasil encounters FDA roadblock     Not so NICE for Avastin     Sen. Grassley seeks NIH transparency     FDA bonuses rise       Industry/Agency Revolving Door Hits Spear In Nose, But Firm Relaunches ANDA     FDA Concludes Entire Antiepileptic Category Poses Suicidality Risk     Clinical Trial Certification: Companies Say IND Submissions Should Be Exempt     ClinicalTrials.gov Requirements Continue To Baffle Firms And Feds Alike       Medicare Bill Strikes Out Again In Senate After Home Run In House     E-Pedigree Could Be A Key Law Enforcement Tool, J&J Exec Says       Chart: FDA Recalls -- June 11, 2008     Chart: FDA Recalls -- June 4, 2008       CDER Staffing Is Real Culprit Behind Missed User Fee Dates – FDA Official       Steifel Rides Ailing Barrier Into Pediatrics Market       McClellan Sees Budget Driving Policy In ’09, Not Coalitions Or New President       Featured Event: The Road to FDA Approval

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