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CDER Staffing Is Real Culprit Behind Missed User Fee Dates – FDA Official

Executive Summary

SAN DIEGO - Even with its new, more aggressive hiring campaign, the Center for Drug Evaluation and Research will take up to a year or more to become fully staffed, a CDER official said June 22 at the Biotechnology Industry Organization annual conference

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CDER New Drug Reviews Are At 80%-90% Of User Fee Goals, Jenkins Says

The Center for Drug Evaluation and Research's performance in review applications for new drugs and biologics within the timelines specified by the Prescription Drug User Fee Act has slipped to 80 percent to 90 percent

CDER New Drug Reviews Are At 80%-90% Of User Fee Goals, Jenkins Says

The Center for Drug Evaluation and Research's performance in review applications for new drugs and biologics within the timelines specified by the Prescription Drug User Fee Act has slipped to 80 percent to 90 percent

CDER New Drug Reviews Are At 80%-90% Of User Fee Goals, Jenkins Says

The Center for Drug Evaluation and Research's performance in reviewing applications for new drugs and biologics within the timelines specified by the Prescription Drug User Fee Act has slipped to 80 percent to 90 percent

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