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 San Miguel Arcangel arcÃ¡ngel is A spanish mission In San, Miguel San Luis Obispo, County. California it was established On july, 25 1797 by The franciscan, order on a site chosen specifically due to the large number Of Salinan indians that inhabited the, area whom The spanish priests wanted to. evangelizeeatures [edit]. 1  The Mission Arcade, a series of 12 arches, is original. 2  The first chapel on the site was replaced within a year of its construction by a larger adobe chapel, which burned in the 1806 fire. 3  The current mission church was built between 1816 and 1818. 4  The cemetery adjacent to the church holds the remains of 2,249 Native Americans ...