FHA News

Outsourcing Best Practices

Outsourcing is a part of our daily reality in the pharmaceutical industry.  Both pharmacovigilance and medical affairs are utilizing outsourced resources to a greater and greater extent.  Fiore Healthcare Advisors shares experience and perspectives on how to extract appropriate value from outsourcing.  Please read our piece in Life Science Leader.


Postmarketing Safety Data Drives Significant Value Even in the Absence of Identified Signals - Part 1 of 3

Postmarketing safety data is significant even when there are no new signals identified. Pharmaceutical and biotechnology companies should develop a pharmacovigilance/drug safety system that can draw firm conclusions from spontaneous safety data and make the data publicly available. Doing so serves to increase market trust of the company as well as continue to "validate" the safety profile of a marketed product.

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Beyond Competitive Advantage - Who should be trusted to distribute a product requiring a REMS?

Researchers from the Brigham and Women's Hospital and Harvard Medical School published a Perspective in the New England Journal of Medicine (NEJM) describing some examples of possible outcomes resulting from intellectual property and other protections afforded to Risk Evaluation and Mitigation System (REMS).

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