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CAPLA sponsors should confer with CBER 12-18 months prior to filing -- CAPLA guidance.

Executive Summary

CAPLA SPONSOR SHOULD CONFER WITH CBER 12-18 MONTHS PRIOR TO SUBMISSION if its computerized application is designed for use on a network system. The Center for Biologics Evaluation & Research outlines an 18-month timeline for submissions in its "Computer Assisted Product License Application Guidance Manual" released March 21. The 12-18 month prior notice will assist the agency and the sponsor in determining whether the submission will require modification of CBER systems to accommodate the filing and "allow time for CBER to plan for the modification," the guidance states.
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PS027859

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