FDA Mulls Alternative Approval Path, Feedback Mostly Positive
By Catherine Shaffer
Tuesday, February 5, 2013
The FDA convened a public hearing to receive input on its proposal to expedite development of new drugs for serious or life-threatening conditions with unmet need. The pathway, which is being considered primarily for development of agents to combat antibiotic-resistant infections, would involve smaller, faster clinical trials with narrow, tightly enforced labeling for use in patients without other options.
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