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Electronic submission of final printed labeling: FDA pilot program slated for early 1997.

This article was originally published in The Tan Sheet

Executive Summary

ELECTRONIC SUBMISSION OF NDA FINAL PRINTED LABELING PILOT PROGRAM is scheduled to begin in early 1997, FDA Center for Drug Evaluation & Research Director Janet Woodcock, MD, told the Food & Drug Law Institute annual educational conference Dec. 10. Under development by FDA and the Pharmaceutical Research & Manufacturers of America, the program will allow companies to submit final labeling electronically in lieu of multiple paper copies. Eventually, FDA expects to use the Internet to conduct negotiations over final labeling as well.
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