Study: 'No link' between approval time, drug safety

A news study conducted by researchers at Tufts argues that quicker FDA approval times for new drugs has had little or no impact on drug safety. That argument runs counter to critics who in part blame looser rules for the jump in safety problems in recent years. Researchers at the Tufts Center for the Study of Drug Development found that in the 1980s, 3.2 percent of drugs approved for sale in the US market were recalled. The authors note that since the year 2000, that number has fallen to 1.6 percent, which if you look at it one way suggests that things are getting better. On the other hand, critics have questioned Tufts before. The CSDD finding that the average cost of developing a new drug is $897 million has been the subject of spirited debate for years.

- see this article from Eye for Pharma
- see this report from the Washington Biotechnology and BioMedical Association