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The FDA has this initiative,” states Michael Stocum, Managing Director of Personalized Medicine Partners LLC, and former Director Business Development and Alliance Management at GlaxoSmithKline’s Human Biomarkers Center. FDA has begun to consider whether a therapy already approved should require labeling As the guidelines are still under construction, the FDA has begun to consider whether new drug applications and therapies already approved should require labeling based on new pharmacogenomic information and testing associated with it (Wechsler, 2004).

Manufacturers voiced their concerns regarding drug-device development. One participant noted that a “partner product” approach, where different companies may manufacture the therapy and the device, might be a good approach. They stated that the FDA needed to be flexible in its guidelines, and consider different scenarios where either the diagnostic test or the therapy could develop first, or both develop simultaneously. “What I’ve seen lately from the FDA is very encouraging in terms of their recognition that companion products are going to be a part of the future and are already appearing now.

The FDA is currently working on guidelines surrounding devices. com • Reproduction prohibited Biomarkers in Clinical Development: Implications for Personalized Medicine and Streamlining R&D can identify which patients should be treated with these therapies is what the regulators are seeking. ” Manufacturers voiced their concerns regarding drug-device development. One participant noted that a “partner product” approach, where different companies may manufacture the therapy and the device, might be a good approach.

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