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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Newtonia, Missouri. Newtonia is a village in Newton County, Missouri, United States. The population was 199 at the 2010 census. It is part of the Joplin, Missouri Metropolitan Statistical Area. Newtonia was the site of the Battles of Newtonia. Newtonia has some Antebellum houses, such as the Ritchey Mansion, as well as a cemetery for Civil War dead. It is a farming community and is immediately adjacent to Stark City, Missouri. In 2008, a tornado struck the village damaging many homes including the Ritchey Mansion.