§ 316.23. Timing of requests for orphan-drug designation; designation of already approved drugs.
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/us/cfr/t21/s§ 316.23·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)A sponsor may request orphan-drug designation at any time in its drug development process prior to the time that sponsor submits a marketing application for the drug for the same rare disease or condition.
(b)A sponsor may request orphan-drug designation of an already approved drug for an unapproved use without regard to whether the prior marketing approval was for a rare disease or condition. [78 FR 35133, June 12, 2013]
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§ 316.23
Timing of requests for orphan-drug designation; designation of already approved drugs.
Fed. Reg.×6
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