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CDER Takes Steps To Meet First-Cycle Review Goals Of GRMP Guidance

Executive Summary

ATLANTA - An agency-wide initiative to implement Good Review Management Principles at the Center for Drug Evaluation and Research should lead to more first-cycle reviews, CDER Associate Director of Regulatory Affairs Kim Colangelo said at a June 18 session of the Drug Information Association annual meeting

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Sponsors and FDA reviewers will have to adjust to the workload of a drug review shifting earlier in the review cycle as the agency implements Good Review Management Principles, now renamed the "21 Century Review Process.

FDA Says New GRMPs Will Shift Drug Review Workload To Earlier In Cycle

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