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 Viejo, Aurora, Colorado. Mission Viejo is a subdivision of Aurora, Colorado, in the Denver-Aurora Metropolitan Area. It is bordered by Buckley Road to the east, Hampden Avenue to the north, Chambers Road to the west and Quincy Avenue to the south. The land on which Mission Viejo lies was once a homestead at the corner of Quincy Avenue and Chambers Road.