FDA Launches Two-Prong Attack On Drug Shortages

Law360, New York (October 31, 2013, 4:46 PM EDT) -- The U.S. Food and Drug Administration on Thursday widened its increasingly intense campaign to rein in an epidemic of drug shortages, issuing a new regulation requiring drugmakers to alert the agency of supply disruptions and laying out a broad strategy for ensuring production of life-saving medicines.

In a proposed rule, FDA spelled out notification guidelines called for under last year’s user-fee law, generally mandating that manufacturers inform regulators of looming shortages at least six months in advance. If that isn’t feasible, companies should give FDA a...
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