The Rising Importance of Observational Research

Regulators are increasingly focusing on safety post-approval and are demanding more data from larger and more-representative patient populations. Payers also want more data to demonstrate cost effectiveness. Physicians are driving the need for data showing quality of life and treatment […]

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Are Pharma Brands Worth Protecting?

This year’s Product Security Supplement, despite all the new technologies being offered, and despite the continued progress on the standards-setting and regulatory fronts, represents a three-year downward trend. In 2008, the industry was reaching a fever pitch, but that fever […]

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How to Think About Companion Diagnostics

Advances in genetics and biochemistry—personalized medicine—promise to tease apart factors that explain why some patients benefit dramatically from a therapy while others receive no benefit at all, and lead some to experience undesirable side effects. For these and other reasons, […]

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Mid-Course Corrections for REMS

Risk Evaluation and Mitigation Strategies (REMS)—a topic that we’ve covered extensively in the past year—was the subject of a public meeting at FDA’s headquarters in late July. The meeting, essentially a continuation of the public comment period when FDA issued […]

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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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