By Michael McCaughan
Six months into the new era of drug safety regulation, one thing is clear: sponsors should view the new post-marketing...
The Impact of FDAAA On Drug Approvals: Setting the Baseline
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An analysis of the first six months of the new era in drug regulation shows that FDA is enthusiastically and creatively applying its new drug safety tools. Biopharma companies will be watching carefully to see how the metrics of the FDAAA era move over time.
Learn what's happening at the US FDA. On the go.
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