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  • The Value of Reviewing Existing EU Risk Management Plans

    Media Coverage — February 12, 2010
    Drug Safety experts Cheryl Key, Barry Mulchrone and Karen Wai describe an electronic database for tracking RMPs for drugs approved in the European Union and explain why it is crucial for sponsors submitting marketing applications to have a thorough knowledge of safety plans already required for similar products.

  • New FDA Guidance on Antidiabetic Therapies

    White Paper — December 11, 2009
    Understanding the FDA Guidance on Assessing Cardiovascular Risks for new Antidiabetic Therapies. Learn what FDA cardiac safety requirements may mean for your development program.

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