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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St. Joseph is a city in and the county seat of Buchanan County, Missouri, United States. It is the principal city of the St. Joseph Metropolitan Statistical Area, which includes Buchanan, Andrew, and DeKalb counties in Missouri and Doniphan County, Kansas. As of the 2010 census, St. Joseph had a total population of 76,780, making it the eighth largest city in the state, third largest in Northwest Missouri. The metropolitan area had a population of 127,329 in 2010. St. Joseph, named after the bib