This status is referred to as orphan designation (or sometimes âorphan statusâ). For a drug to qualify for orphan designation both the drug and the disease or condition must meet certain criteria specified in the ODA and FDAâs implementing regulations at 21 CFR Part 316.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.
Mission Viejo /ËmÉªÊÉn viËËeÉªhoÊ/ is a city in Orange County, California, United States in the Saddleback Valley. Mission Viejo is considered one of the largest master-planned communities ever built under a single project in the United States, and is rivaled only by Highlands Ranch, Colorado, in its size. Its population as of 2014 was estimated at 96,346.
Mission, South Dakota. Mission is a city in Todd County, South Dakota, United States, within the boundaries of the Rosebud Indian Reservation. The population was 1,182 at the 2010 census. Mission is home of the Sinte Gleska University. It is the largest incorporated community in the county, but is smaller than the unincorporated community of Rosebud, the capital of the Rosebud Sioux Tribe. It is named for one of the many missions established by religious groups in the late 19th century to educate and assist the Sicang