CDER final printed labeling electronic submission pilot program slated to begin in early 1997.

Executive Summary

NDA FINAL PRINTED LABELING ELECTRONIC SUBMISSION 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's educational conference in Washington, D.C. 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.