A sponsor seeking orphan designation for a drug must submit a request for designation to OOPD with the information required in 21 CFR 316.20 and 316.21. Each designation request must stand on its own merit.afety and effectiveness of a drug must be established through adequate and well-controlled studies. The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product (âdrugâ) to treat a rare disease or condition upon request of a sponsor.
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Its county seat is Warrensburg. The county was formed December 13, 1834 from Lafayette County and named for Vice President Richard M. Johnson. Johnson County comprises the Warrensburg, MO Micropolitan Statistical Area, which is also included in the Kansas City-Overland Park-Kansas City, MO-KS Combined Statistical Area.