"Having worked on this for many years, the judge really wanted to make it clear that FDA had come to a scientific determination and was once again overruled, and that is not acceptable, " she added.
It is clear if the FDA is asking manufacturers to do new studies on these drugs, it does not 100% trust its effectiveness and safety.
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The current law, displaying a peculiar lack of hindsight, virtually guarantees that the FDA will clear new products proven to be sufficiently similar to ones already approved, even in cases when they contain the same design flaws that have prompted recalls of the latter.
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The company had previously disclosed the existence of the letter in an SEC filing but did not make clear the full extent of the FDA warning.
Although not harping on the role of the FDA, it is clear from the analysis that pretty much the entire collapse was due to delayed product approval.
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However, it's not clear whether such a dose could get past the FDA on its own.
In 2010, CDER and GSK saw an opportunity clear Avandia of any cardiovascular hazard and scheduled an FDA Advisory Committee meeting to exonerate the drug.
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In a bi-partisan display of pork barrel politics, Congressional officials in Northwest salmon country are making it clear that they will pull out all stops to block the FDA from issuing a final approval letter.
The task is so difficult that the FDA has allotted three days for the work, a clear sign of controversy.
The FDA is adamant, though, that the organic stuff is far from in the clear.
Iressa won the backing of an FDA panel last September, which was a surprise because the drug had yet to demonstrate a clear survival benefit and failed to help at all when added to chemotherapy.
"FDA may do some inspections, but we have limited resources to inspect produce operations and we have a clear direction from Congress to collaborate with state agencies so we expect much of the oversight to come at the state and local level, " Taylor said.
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