The first use of the name Old Fashioned for a Bourbon whiskey cocktail was said to have been at the Pendennis Club, a gentlemen's club founded in 1881 in Louisville, Kentucky.
From Wikipedia, the free encyclopedia. The European Medicines Agency (EMA) is a European Union agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.
The EU's definition of an orphan condition is broader than that of the USA, in that it also covers some tropical diseases that are primarily found in developing nations. Orphan drug status granted by the European Commission gives marketing exclusivity in the EU for 10 years after approval.The EU's legislation is administered by the Committee on Orphan Medicinal Products of the European Medicines Agency (EMA).or example, orphan drug regulations generally acknowledge the fact that it may not be possible to test 1,000 patients in a phase III clinical trial, as fewer than that number may be afflicted with the disease in question.