By Michael McCaughan
Maybe it’s the acronym. When Congress settled on the term Risk Evaluation & Mitigation Strategies as the catch-all term for...
Waking Up to REMS (Part 1): Don't Believe the Lack of Hype
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FDA's top management can't be accused of overstating the importance of the agency's new drug safety tools. But sponsors need to wake up to the reality: the REMS are a critical fact of drug development and marketing.
Learn what's happening at the US FDA. On the go.
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