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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Welcome to California, Missouri! The family-oriented community, home to about 4,000 residents, is strategically located in the central Missouri area, with great access to business centers, shopping, activities, beautiful parks and the Moniteau County Fair. Citizens enjoy a thriving economy in the heart of Moniteau County.