Submitting Biologics Applications to the Center for Biologics Evaluation and Research Electronically
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Drug Information Journal. Vol. 33. pp. 1-15, 1999 Printed in the USA. All rights reserved.
SUBMITTING BIOLOGICS APPLICATIONS TO THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH ELECTRONICALLY MARYA. BUESING,MD Medical Review Officer
EDWARD MCSWEEGAN, PHD Program Officer Center for Biologics Evaluation and Research, Food & Drug Administration, Rockville, Maryland
The Food and Drug Administration (FDA) has gained significant experience with computer-assisted licensing applications, and has concluded that continued reliance on customized formats is a burden for the FDA and industry. As a result, the FDA is working to standardize the content and format of electronically submitted applications, and to establish procedures for electronic applications that will: create minimal additional work for industry and reviewers, establish consistency across the FDAS centers, and expedite the review process. The FDA is proposing to move to a paperless regulatory process by the year 2002. Toward that goal, the FDA> Center for Biologics Evaluation and Research (CBER) has released new guidance for the electronic submission of biologic and product license applications; case report forms, tabulations, and statistical data; and lot release protocols. A pilot program for Investigational New Drug applications also has been initiated. Key Words: Investigational New Drug; Biologic product license; Electronic; Guidance;
CBER feet of storage space. Currently, CBER is spending over $1 million per year to archive APPLICAT1oNS RECENTLY submitted to and manage linear miles of paper applicathe Center for Biologics Evaluation and Re- tions. The expenditures and logistics search have averaged between loo and 150 to store, distribute, and review this amount Of paper per These pa- of paper have become overwhelming. Moreper may Some 23 linear over, it has become a burden for h e pharmaceutical and biotechnology industries to produce this amount of paper documentation, and to maintain their own application arPresented at the CBER-DIA Workshop “Electronic Submissions of Biologics,” May 22, 1998, Washington, chives. The preparation of a paper applicaDistrict of Columbia. tion is estimated to cost a sponsor between Reprint address: Edward McSweegan, PhD, National of Health, NIAID,,,MID, Bldg,, $0.5 and $1.0 million in terms of materials, Rm. 3A34, Bethesda, MD 20892. E-mail: mcsweegan labor, shipping, and storage ( 1. @nih.gov. The advent of high-speed electronic com-
INTRODUCTION
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Mary A. Buesing and Edward McSweegan
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munications systems and powerful, inexpensive desktop computers offers a means of curtailing the growing volumes of paper applications. Recent Congressional legislation also encouraged CBER and industry to pursue electronic solutions to the preparation and reviewing of biologics applications, and to reducing the time to review applications. The FDA is using funds provided under the 1992 Prescription Drug User Fee Act (PDUFA) to establish an information technolo
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