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REGULATORY:
Approvals of Innovative Drugs by FDA Surpass EU, CanadaYale study challenges notion that the FDA lags behind its peers.
A new report comparing health regulatory agencies in the United States, the European Union, and Canada reveals that the U.S. Food and Drug Administration has approved more new, innovative medicines faster than both the European Medicines Agency and Health Canada in the last decade. Read More
- Military Veterans Support Alternative FuelsRetired generals warn Congress that national security is at risk. Read More.
Regulatory
User Fee Deal Eased Some Burdens, Exacerbated Others, Report SaysTufts Center for the Study of Drug Development says supplemental new drug and biologic licenses grew more onerous. Read More.Patents
Bayer Appeals Forced Licensing in IndiaIssue creates friction between government trade representatives. Read More.Regulatory
Keeping Score at the FDA Podcast: May 14, 2012 Read More.Regulatory
Groups Weigh in on BiosimilarsNaming, interchangability key focus of discussions. Read More.Trade
Friction for Pharma Abroad, But Progress TooU.S. trade report cites trading partners’ wrongs. Read More.Regulatory
FDA’s Woodcock Argues for Clinical Research MakeoverAcademia can and should play a greater role in bringing better drugs to market, says CDER director. Read More.Regulatory
FDA Stretches to Go GlobalWith limited resources, agency targets trouble spots and seeks cooperation. Read More.Commentary
P2P Healthcare and the Portals of PowerPharma should embrace social media and its creative destruction. Read More.Litigation
Novartis Challenging Avastin Use for Eye Disease in the U.K.Lawsuit claims patient safety is being compromised. Read More.Court Rulings
Generic Drugmakers Score Victory at Supreme CourtCaraco case hinged on semantics. Read More.Healthcare Reform
Berwick Says Billions Can Be Saved through Cutting WasteFormer CMS administrator supported Affordable Care Act, but sees more opportunity for savings. Read More.Generics
Drug Shortages and the Role of the Middle ManGroup Purchasing Organizations are a little understood driver of the problem. Read More.Regulatory
Forging a Launch Pad for Emerging Growth IPOsPodcast: April 9, 2012 Read More.Healthcare Reform
GAO Sees Gloomy Fiscal Outlook without Health ReformLong-term simulations show federal deficits and debt on the rise without reforms. Read More.
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