Mini Sentinel Alleviates FDA Concern Over Pradaxa Bleeding Issue
This article was originally published in The Pink Sheet Daily
Data from the pilot program a “driving factor” in the agency’s decision against changing its recommendations for the blood thinner following reports of increased serious bleeding events.
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Growth of post-market surveillance system also may require more resources.
Revamped ANDA instructions – among new and revised draft guidance for 58 products announced by FDA – 'account for the fact that dabigatran exhibits large within-subject variability with respect to blood levels.'
Settlement expected to resolve approximately 4,000 Pradaxa personal injury claims.