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Executive Summary

Computer-assisted submissions to FDA's Center for Drug Evaluation and Research currently make up about 10% of the NDA workload, CDER Office of Management Director Robert Bell said at a Pharmaceutical Manufacturers Association/FDA jointly sponsored meeting on computer-assisted NDAs (CANDAs) held July 16-17. "There seems to be a large number of CANDAs beginning to come into the agency," Bell noted. "If we look at just a couple of years ago you had two, three, or maybe four [CANDAs a year]. We're now getting 10% of our workload on computer-assisted format." Computer-assisted submissions to FDA include full and partial CANDAs, as well as one IND. The FDAer added that CDER now has "over 800" personal computers. CDER has received "over 40 CANDAs involving over 20 companies," Bell said. Of those 40 submissions, 12 have been approved: Terazol 3, CoAdvil, Diflucan (oral and I.V. forms), Zefazone, Hytrin, Voltaren, Cartrol, Pindac, Procardia XL, Toradol, and Betoptic. Of the 12 approved CANDAs, Terazol 3, CoAdvil, Diflucan, and Zefazone had relatively short reviews. Bell said that "the overall average time on those five [NDAs] is 17 months, instead of the normal 28." The CANDAs for the five drugs were submitted simultaneously with the paper versions. FDA is looking into what factors contributed to the reduced review times. Bell suggested that it may be time for FDA to come out with guidelines on CANDA submissions. "I don't believe we're ready for standards, but...I sure hope we can use the information and knowledge that we've gained to date and through this conference to be able to put out some guidelines," Bell said. The guidelines could include "features that seem to work and those that don't" and "ideas about what's in-house and how it can be used." FDA Division of Cardio-Renal Drugs Director Raymond Lipicky, MD, discussed his division's experience with CANDAs and what features reviewers preferred in CANDAs. Lipicky noted that reviewers in his division wanted full text capabilities, the ability to cut and paste, and the capability of doing data analysis. Reviewers also like to be able to see case report forms and "browse through them," Lipicky said. However, he pointed out that "page-image optical disk systems are of absolutely no value as a primary review tool." Stressing the importance of providing reviewers with electronic review equipment of their preference, Lipicky said "FDA should create the environment that the reviewer needs, the computers, the software [and] the word processor." He noted that his division possesses a "very mixed system" of computers. The Cardio-Renal Division director indicated that CANDAs do not necessarily mean shorter review times. He stated that speed is "not an objective [and] it will never be assessable." Lipicky pointed out that, at present, the primary advantage of CANDAs may be in facilitating a quality review by allowing quick database searches and increasing reviewers' familiarity with the data. The FDAer also emphasized the importance of retaining the paper-bound NDA -- "not just the integrated summary, but the entire words that are in the written part of the NDA. [They] just cannot be replaced." FDA Pilot Drug Evaluation Staff Director John Harter, MD, suggested that CANDAs be used during the development stage of a drug in order to improve and speed up the process. "Clearly, if the FDA were to be looking at these studies during the IND and finding out what was wrong with them and reaching agreement with the sponsor about those, it might be possible when the NDA came in to turn it around in 180 days." Harter coined this procedure as "CAINDAs." Harter noted that one of his staff's goals is "to do NDA reviews in 180 days." He added that "right now it's a dream. I'd like to get it to the goal stage." The staff believes that "the NDA Day concept has helped us shorten the time of tertiary review." However, the FDAer pointed out, "we're a long way from finishing one in 180 days."

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