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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Arrow Rock, MO. Arrow Rock is a village in Saline County, Missouri, United States. The population was 79 as of the 2000 Census (56 as of the 2010 Census). The musical Tom Sawyer (1973), based on the novel by Mark Twain, was filmed here. Arrow Rock Historic District has significant properties and the George Caleb Bingham House has been designated a U.S. National Historic Landmark.