CFR 21-316.23-2013
Food and drugs. Part316:Orphan drugs. Section316.23:Timing of requests for orphandrug designation; designation of already approved drugs.

Standard No.

CFR 21-316.23-2013

Release Date

2013

Published By

US-CFR-file

Latest

CFR 21-316.23-2013

Scope

(a) A sponsor may request orphandrug designation at any time in its drug development process prior to the time that sponsor submits a marketingapplication for the drug for the same rare disease or condition.

CFR 21-316.23-2013 history

• 2013 CFR 21-316.23-2013 Food and drugs. Part316:Orphan drugs. Section316.23:Timing of requests for orphandrug designation; designation of already approved drugs.