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FDA to List Drugs Under Review for Safety Issues
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Page: << Prev | 1 | 2 Drugs under investigation before 2008 or after March aren't included on the current list. Dal Pan said he wasn't sure when an updated list would be posted.
FDA officials emphasized that people taking drugs on the list should not overreact and stop taking them.
"As always, we are very sensitive to the potential misinterpretation or over-interpretation of any potential unintended consequences because the drug is on the list," Dr. Paul Seligman, the associate director of Safety Policy and Communication at the FDA's Center for Drug Evaluation and Research, said during the teleconference.
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"There is always the risk that anytime you put something in writing and post it on an official FDA Web site that people will read into it more than that we are just conducting a review," Seligman said. "We are expecting people not to take actions simply based on the fact that we are evaluating a particular drug."
In addition to providing the public with more information, the agency thinks the list will encourage more reporting of adverse events.
More information
For more on drugs under review, visit the U.S. Food and Drug Administration.
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Copyright © 2008 ScoutNews, LLC. All rights reserved.
Last updated 9/5/2008
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SOURCES: Sept. 5, 2008, conference with Gerald Dal Pan, M.D., M.P.H., director, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER), Paul Seligman, M.D., M.P.H., associate director of Safety Policy and Communication, CDER, both with U.S. Food and Drug Administration
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