FDA Details Steps For Streamlined Antibiotic Approval

Law360, New York (July 1, 2013, 5:48 PM EDT) -- The U.S. Food and Drug Administration on Monday released highly detailed guidance on development of next-generation antibiotics, the latest chapter in the federal government’s effort to tackle mounting resistance to bacterial infections and lagging introduction of new treatments.

The guidance, which the FDA was required to issue under last year’s drug industry user-fee law, goes into significant detail discussing clinical trials and the attributes that new antibiotics must possess to qualify for streamlined approval.

Several situations could present an “unmet medical need” that warrants speedier regulatory...
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