Smoothing the Path to Drug Safety

The FDAA Act of 2007 empowered the FDA to require Risk Evaluation and Mitigation Strategies (REMS) for new and existing pharmaceutical products. After the first programs were introduced in 2008, REMS have now become an established part of the pharmaceutical […]

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Pharma, FDA Wrestle with Social Media Tools

The fast-changing nature of the Internet continually opens new opportunities for communicating with consumers and physicians. It also brings new regulatory challenges, as the FDA struggles to keep up—and pharmaceutical companies try to take advantage of technology without falling foul […]

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Defending Fair Market Value (FMV) Assessments

“Fair market value” is a legal term that tries to define the appropriateness of payments when there are conflicting or at least multiple justifications for those payments. FMV turns up in many business transactions, but specifically in payments occurring where […]

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Deloitte 2010 Survey of Health Care Consumers

The 2010 Survey of Health Care Consumers, conducted by the Deloitte Center for Health Solutions, is Deloitte’s third annual study of consumers’ attitudes, behaviors and unmet needs. Deloitte’s survey measured consumers’ views and actions across a wide range of issues […]

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The Drive to Develop New Commercial Models

By all accounts, biopharma executives have a complex 2010 agenda, requiring that they work tirelessly to: Reconsider their basic business models while driving efficiencies in their in-line assets, with 75% of mature markets being undifferentiated (see box) by 2015 Improve […]

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