FDA working to meet drug deadlines
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NEW YORK (Reuters) - U.S. regulators are aiming to meet more drug approval deadlines after what may have been the worst year for evaluating products on time, a senior Food and Drug Administration official said on Tuesday.
The FDA agreed to meet 90 percent of the target dates for approving new medicines but has missed several this year.
When figures are tallied for fiscal year 2008, "they're probably going to be, in many areas, lower than they've ever been before," Dr. John Jenkins, director of the FDA's Office of New Drugs, said at the Reuters Health Summit in New York.
"I'm hoping that's going to be the nadir, and then we're going to start turning back up toward getting back to that goal of 90 percent," Jenkins said.
The FDA has not grown more conservative in judging a drug's risks, as some industry executives complain, but is applying new understanding about potential side effects to reviews, Jenkins said.
"As we learn more about safety issues, we apply that new information to products we are reviewing. It would be irresponsible of us as a public health agency not to do that," he said.
(For summit blog: summitnotebook.reuters.com/))
(Reporting by Lisa Richwine and Susan Heavey; Editing by Gerald E. McCormick)
