Drug Approvals After First-Cycle Review Decline, Parexel Report Finds
Executive Summary
FDA's Center for Drug Evaluation & Research cleared fewer NDAs after one review in 2005 than it did the previous year, according to Parexel International's Bio/Pharmaceutical R&D Statistical Sourcebook 2007/2008
You may also be interested in...
CDER Takes Steps To Meet First-Cycle Review Goals Of GRMP Guidance
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
CDER Takes Steps To Meet First-Cycle Review Goals Of GRMP Guidance
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
First-Cycle Approvals May Rise For Second Consecutive Year – Parexel Report
First-cycle approvals by FDA's Center for Drug Evaluation & Research may continue to rise for a second consecutive year, according to Parexel's Bio/Pharmaceutical R&D Statistical Sourcebook 2006/2007