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Drug Approval Process Improving
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Page: << Prev | 1 | 2 Still, numbers aren't everything and many experts, including McGrath, do see hopeful signs.
"Apparently, the FDA's communication of what they would like in a new drug application is being listened to by industry and leading to a more efficient application review process, which hopefully translates into benefits for both the FDA and the company," says Dr. A. Mark Fendrick, a professor of internal medicine at the University of Michigan School of Medicine and a professor of health management and policy at the University of Michigan School of Public Health.
In particular, Fendrick says, pre-application meetings between FDA officials and those in the drug industry seem to be contributing to a stepped-up efficiency, as they result in applications which, as Jenkins puts it, "are in better condition for approval."
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"My view is that, as companies get more comfortable dealing with pre-application programs, we're going to continue to see increases in efficiency on both the industry and the agency side," Fendrick says.
It also helps that the FDA has a commissioner, Dr. Mark McClellan, after having gone about two years without one, and that he has made drug development a priority, Jenkins adds.
"Bringing in a player like McClellan has certainly energized the agency," Fendrick says. "It appears under the McClellan administration that the FDA is taking this approval time issue very seriously."
The FDA has stated it wants to eventually reduce review time by 10.5 percent by reducing multiple cycle reviews (that's when the FDA tells a company it needs to change something and the process starts over from scratch) and initiating even earlier communication with manufacturers.
The actual number may be less important than the process behind it, McGrath says. "They talked about 'focused communication with product developers about FDA standards.' That sounds vague, but it's something that can make a big difference," he says. "They're saying that we realize we should meet with them right away and, if they really do, that's an important thing... A more important objective is that the review time will drop. And if that happens, then more deserving drugs will be approved and drugs that are not deserving will not be approved."
More information
The FDA has more on new drug development (www.fda.gov) and on last years new molecular entities (www.fda.gov). Page: << Prev | 1 | 2
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Copyright © 2004 ScoutNews, LLC. All rights reserved.
Last updated 1/19/2004
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SOURCES: John Jenkins, M.D., director, Office of New Drugs and Center for Drug Evaluation Research, U.S. Food and Drug Administration, Rockville, Md.; A. Mark Fendrick, M.D., professor, internal medicine, University of Michigan School of Medicine, professor, health management and policy, University of Michigan School of Public Health, Ann Arbor, and editor-in-chief, American Journal of Managed Care; W. Patrick McGrath, Ph.D., executive director, Office of Industrial Liaison, Mount Sinai School of Medicine, New York City
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