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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Missouri. Missouri is a state in the Midwestern region of the United States bordered by Iowa, Illinois, Kentucky, Tennessee, Arkansas, Oklahoma, Kansas and Nebraska. Missouri is the 18th most populous state. It comprises 114 counties and one independent city. Missouri's capital is Jefferson City.