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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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. Submission of final printed labeling "is a very onerous part of the review process," Woodcock said. "You have to file 25 copies of the labeling with us and then we have to do something with them. What we would like to get is an archival repository where anybody who would want to look at the current label of any drug could just call up on the Internet and get that currently approved label." The pilot program would be followed by a guidance on the electronic submission of final labeling. Woodcock indicated that FDA's ultimate goal is "an all-electronic process and electronic communications....We would hope that if we are successful and we do have a user fee program in the next coming years,...we would be able to have this all finished by the year 2000. I think this is very feasible with today's technology." How rapidly FDA is able to implement electronic submission procedures "is contingent on the reauthorization of the user fee program," Woodcock remarked. "But this is the direction" in which the agency "need[s] to go...regardless of what the source of funding [is] or how much funding we have." The labeling pilot is one of several steps FDA is taking towards electronic data submission. The agency also is developing guidance on the electronic submission of case report forms. Woodcock noted that case report forms constitute "the biggest part of NDAs right now....If we could move that into electronic-only filing, we would be shrinking that mound considerably, saving everybody who is involved in that process a lot of resources. We had a public meeting on this with DIA recently, and there are a lot of technical issues that have to be solved, but we think we can get to this in 1997." FDA also is preparing a final rule on electronic signatures, which, Woodcock said, "will allow the agency to accept electronic-only filings as official filings." The CDER director is pressing to have the rule on electronic signatures published by the end of the year. |