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Janet Woodcock

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“ We need to work with pharmacy operators, drug manufacturers, healthcare professionals and consumers to come up with a sensible, comprehensive and more effective solution ”
FDA criticizes medication information
United Press International
“ We cannot rule out, however, that some of these patients were dehydrated prior to ingestion of OSP products or they did not drink sufficient fluids after ingesting OSP products ”
FDA orders bowel cleanser safety warnings
United Press International
“ As part of FDA's monitoring of the life-cycle of approved products, the agency received reports of serious infections in some patients taking Raptiva, These reports led to our decision to highlight these risks in the drugs labeling ”
FDA OKs Raptiva drug labeling changes
United Press International
“ My message to patients is this: Don't stop taking your medicine. If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently ”
FDA posts drug-safety watch list
United Press International
“ Modern science has advanced since, and this is an opportunity to apply modern science to evaluate these products ”
Children medicines to be reviewed
United Press International
“ It acts like heparin in this test, so it looks like everything is fine in the test ”
Foreign substance found in Baxter heparin
United Press International
“ The keystone of the current system is the prescriber and that person is the one who decides if the benefits of a drug outweigh the risks for that patient ”
FDA official: Safety system broken down
United Press International
“ We are looking now at imaging ... we saw for some products you can image where they go and what organ they are in and how long they stay in the body ”
Feature: FDA seeks updated research tools
United Press International
“ A proportion of people treated with this drug in the last decade had mild acne and should've been treated with other drugs. ”
Hill committee: Accutane causes suicide
United Press International
“ With respect to psychiatric events, our advisory committee agreed that no clear causal link has been established. However, definitive demonstration of causality for a rare adverse event can be difficult to demonstrate. When there is reasonable suspicion of an association, patients should be informed. We are working diligently with the sponsor on this issue. ”
Teen pilot had Accutane prescription
United Press International
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