FDA approvals up in '08, missed deadlines abound

The FDA will approve at least 21 new drugs this year, says the AP, an uptick from last year when only 18 first-of-a-kind therapies gained a green light from the agency. But industry observers note that despite the jump, the FDA missed its review deadlines 15 times over the course of the year, and there's every reason to believe that the agency continues to take a hard look prior to providing marketing authorization. Developers say the FDA is quick to ask for more data prior to approval.

"The conversations are tougher than they were 20 years ago because the issues are tougher," Pfizer Vice President Robert Clark said recently. "Twenty years ago I guaranteed that I would get a new drug application approved, and that's not exactly what I'm saying today."

The FDA, though, says that the industry is largely to blame for the low rate of new approvals. The number of new drug submissions has declined steadily in recent years, the FDA notes. And they can't approve drugs that aren't offered for review.

- view approvals and other November FDA news [1]
- check out the story [2] from the AP

Related Articles:
2008 NME approvals will surpass 2007 [3]
FDA: Don't blame us for sparse approvals [4]
FDA approval drought despite surge in apps [5]
FDA picking up the pace on '08 approvals [6]
FDA official says approval deadlines will be broken [7]