Pharmalot's Ed Silverman says the Food and Drug Administration's new, slower pace for drug approvals is probably the "new normal" for the regulatory body. A new study from Parexel Consulting in Boston shows that the rate of first-cycle drug approvals FDA makes is slowing, and that there's a "significant and ongoing decline" in priority-designation rates, Silverman says. Parexel Consulting found a 25 percent decline in first-cycle approvals for new drugs and a 17 percent decline in priority designations for NDAs between 2008 and 2009, which the firm attributes to FDA's Safety First Initiative and new risk management strategies, among other things. Overall, Silverman says, the agency's actions on diabetes drug Avandia are indicative of its "new normal."
FDA Slows Down
Oct 29, 2010