Avoid Launch Delays By Planning For An FDA-Required REMS Risk
lt;p>Picture this: The FDA accepts a manufacturer's NDA, and the manufacturer plans for its impending launch. But shortly before the anticipated approval, the FDA notifies the manufacturer that a Risk Evaluation and Mitigation Strategy (REMS) program is required to market the product. Now what?</p>
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Avoid Launch Delays By Planning For An FDA-Required REMS Risk Evaluation and Mitigation Strategy
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Frontiers Adaptation for Regulatory Application: A Content Analysis of FDA Risk Evaluation and Mitigation Strategies Assessment Plans (2014–2018) Using RE-AIM
