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.
The Juaneno JuaneÃ±o band Of Mission, Indians Acjachemen nation are the original inhabitants of the lands that ultimately became The county Of, orange as well as parts Of San, Diego Los, angeles And Riverside. countieshe Tribe provided the original manpower for the construction of some of the earliest key landmarks in Orange County, including the Mission San Juan Capistrano. While the American Colonies were being founded on the East Coast, the Acjachemen Indians were conscripted to build the mission here on the West Coast.