Monday, March 18, 2013

FDA 2012 and 2013 acceptances vs denials - hot pursuit

Although the number of new drugs approved by the U.S. Food and Drug Administration (FDA) rose to a 15-year high last year, there have been several high-profile denials so far in 2013, according to a recent announcement made by the regulatory agency. 

The FDA approved a total of 35 novel drugs in 2012. In the last decade, the FDA averaged about 23 approvals per year. According to many analysts, these approvals are likely to increase with the passage of the Prescription Drug User Fee Act (PDUFA). 
The 35 new drugs approved last year included a groundbreaking treatment for a form of cystic fibrosis, the first human cord blood product ever approved and the first drugs to treat advanced basal cell carcinoma—a form of the most common skin cancer—and the bone marrow disease myelofibrosis. 

Read full story

No comments:

Post a Comment