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FDA under pressure to relax drug rules

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Industry says antibiotic pipeline is being blocked by overly stringent clinical-trial requirements for new treatments.

The latest skirmish in the battle between human and microbe played out on 29 November in a hotel conference room in Silver Spring, Maryland. There, an assembly of scientists and clinicians debated the merits of an experimental antibiotic. For some, the coveted prize was not just an endorsement of the drug itself, but a sign that the US Food and Drug Administration (FDA) is finally ready to rethink its clinical-trial requirements for antibiotics ā€” requirements that the drug industry says are unrealistic.

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