Almost half of new molecular entities approved in 2011 considered significant therapeutic advances

作者：Edlin Mari^*

来源：Formulary, 2012, 47(1): 26-+.

Of the 30 new molecular entities (NMEs) approved last year by FDA, almost half of the drugs were considered to be significant therapeutic advances over existing therapies for hepatitis C, stroke, and kidney transplant. The majority of the approved drugs received "priority review," giving FDA a 6-month goal to complete its evaluation for safety and efficacy. About two-thirds of the new approvals did not require giving additional information to FDA, so they were completed in a single review cycle. Approximately 70% of the new drugs were approved in the United States before any other country, including the European Union. (Formulary. 2012; 47:26-38.)

• 出版日期2012-1