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Sentinel May Expand To Generic Equivalence Studies

Executive Summary

Tool being designed for rapid queries of US Sentinel data to consider generic drug switches, potentially spot equivalence problems.

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Sentinel Offers Drug Firms ‘Unique’ Venue For Post-Market Studies, Pfizer Says

Pfizer’s experience in piloting an approach to using US FDA’s Sentinel data network for post-market research demonstrated the feasibility and benefits of doing so.

Complex ANDAs To Be Allowed Pre-Submission Product Meetings

FDA will be able to give scientific advice and sponsors can familiarize reviewers with upcoming generic applications for complex products under new provision in GDUFA II.

ANDA Approval Speed-Up Leaves Sponsors With Less Margin For Error

Get applications in right, or get a complete response letter, FDA says; firms will have fewer opportunities for mid-review application corrections as review goals reach 10 months.

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