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.
Father Junipero Serra chose the site for the Mission in a dedication ceremony on March 31, 1782. The mission is the 9th and the last to be founded by Father Serra before he died. Father Serra dedicated the mission to Saint Bonaventure. Location and Geography : The Mission is located on the upper part of the southern coast just a few miles from the ocean. The city of Ventura grew up around the mission. The Native Americans : The main tribe in the area around Mission San Buenaventura was the Chumash. The Chumash were one of the larger tribes in California.