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But ISO 14971 ranks risk controls in a fixed order: inherently safe design, then protective measures, then information for safety, which means labels and instructions, dead last
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That’s why the FDA’s 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
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