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 Mission Hills Census Designated Place had a population of 3,564 as of July 1, 2015. The primary coordinate point for Mission Hills is located at latitude 34.6888 and longitude -120.4398 in Santa Barbara County. The formal boundaries for the Mission Hills Census Designated Place (see map below) encompass a land area of 1.23 sq. miles and a water area of 0.01 sq. miles. Santa Barbara County is in the Pacific time zone (GMT -8). The elevation is 325 feet.