By Michael McCaughan
The FDA Amendments Act just turned three, and, as far as birthday celebrations go, the Food & Drug Administration's decision...
REMS 2.0: FDA Refining New Drug Safety Tools
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FDA’s new post-marketing risk management authorities are receiving much more public attention in the context of the Avandia decision…but use of the REMS is actually declining. As FDAAA turns 3, it is clear that REMS are going through some growing pains. The new tools will be refined—but they are definitely here to stay.
Learn what's happening at the US FDA. On the go.
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