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		May 12, 2008 Volume 70, Number 19  The Role Of RiskMAPs: Fentora Shows Shift From Post-Market To Pre-Market Cephalon needs to improve the risk management plan for its breakthrough cancer pain drug Fentora regardless of whether it expands use to non-cancer pain patients, according to FDA and a joint Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committee.    READ MORE>> FDA’s Post-Market Pharmacoepidemiologic Study Guidance Is 3 Years Away FDA told participants at a May 7 workshop that it plans to have draft guidance for conducting post-market pharmacoepidemiologic safety studies ready for review in fiscal 2010, with final guidance to be released a year later.    READ MORE>> Sen. Kennedy’s Foreign Inspection Bill Gives FDA More Flexibility Than House House and Senate Democrats are taking similar approaches in regard to invigorating FDA's ability to oversee foreign manufacturing facilities. But some fundamental differences and Republican concerns suggest that the issue will likely not be resolved until at least the next Congress.    READ MORE>>       All-Amgen Denosumab Raises Hopes; Proof-Of-Concept Peek Due At ASCO       Vaccine/Autism Link Weighed In Court; Is HHS Compensation A Precedent?       Medicare IVIG Payment Study, Short-Term Fix Proposed By Sen. Kerry     CMS Will Detail MedCAC Research Role In Response To Industry Concerns       Public/Private Initiative To Help FDA Modernize Guidance For Clinical Trials     Breaking news from “The Pink Sheet” DAILY     GSK’s Promacta slated for committee review     J&J’s Doribax     FDA Science Board meeting     Sen. Kohl fights for more FDA funding       Purdue Effort To Reduce Abuse By Reformulating OxyContin Rejected By Panel     FDA Panel Advice To Limit Aquavan Administration Would Also Limit Market     Advisory Cmte. Endorses Cinryze Unanimously, But HAE Battle Continues       FDA Safety Monitoring Could Rely On Data Links, Menactra Model – McClellan       Rep. Dingell’s Prescription For DTC Offered To Pharma Panel At Hearing       Baxter’s War Games: Post-Heparin, Scientists Consider Supply Chain Threats       Chart: FDA Recalls -- May 7, 2008       Genzyme Sets Sights On 13 Drug Approvals By 2012	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 PharmAsia News
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