Avoid Launch Delays By Planning For An FDA-Required REMS Risk

lt;p>Picture this: The FDA accepts a manufacturer&#39;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.&nbsp;Now what?</p>

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These highlights do not include all the information needed to use FILSPARITM safely and effectively. See full prescribing information for FILSPARITM. FILSPARITM (sparsentan) tablets, for oral useInitial U.S. Approval: 2023

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Avoid Launch Delays By Planning For An FDA-Required REMS Risk Evaluation and Mitigation Strategy

Avoid Launch Delays By Planning For An FDA-Required REMS Risk Evaluation and Mitigation Strategy