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 Santa Cruz Father Lausen, who led the missionary system following Father Serra's death, raised the cross on August 28, 1791 on where Mission Santa Cruz, or Holy Cross, was to be built. On September 25, 1791, the Mission Santa Cruz was formally founded as the 12th California Mission. Mission Santa Cruz is known as the hard luck mission. The first hard luck that the Mission suffered came in the form of floods. The original Santa Cruz Mission was located on the banks of the San Lorenzo River near what is now downtown Santa Cruz.