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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Gladstone is a city in Clay County, Missouri, founded in 1952 and is a suburb of Kansas City, Missouri. Like nearby North Kansas City, the city of Gladstone is now completely surrounded by Kansas City. Prior to 1952 this area was known as Linden. The population was 26,365 at the 2000 census.