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Participation models vary widelyfrom passive monitoring to direct investment in pioneering biotech firmsand the time to define your approach is now

Anderson JL, Muhlestein JB, Horne BD, Carlquist JF, Bair TL, Madsen TE, and Pearson RR (2000)

Thats why the FDAs own technical staff has recommended against expanded access, and the public health group Partnership for Safe Medicines calls them "popular, unproven, dangerous. As Peter Kolchinsky, managing partner of biotech investor RA Capital Management, puts it: Is the FDA going to stand on science or is it going to permit all kinds of snake oil to be readily available? The FDA meeting will last two days

J.MaS.CaprioliR