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Executive Summary

The submission of an NDA using computer technology is conditional on the FDA reviewing division's willingness to accept the application in the computer-assisted NDA (CANDA) format used by the sponsor, the agency said in a "guidance" on CANDAs published in the Sept. 15 Federal Register. For this reason, the guidance points out, "it is important that the acceptability of the proposed CANDA be established, to the degree it is possible, well in advance of the submission, before substantial effort has been expended." A drug sponsor intending to submit a CANDA "is encouraged to discuss its plans with CDER's [the Center for Drug Evaluation and Research's] Office of Management to identify and resolve potential problems involved in filing a CANDA," FDA said. In particular, the agency pointed out, "sponsors should be prepared to discuss possible logistical problems involved in the installation of computer equipment." The guidance begins by "encouraging drug sponsors to explore the use of CANDAs," and directs companies considering computer-assisted submissions to contact Robert Bell, director of the Office of Management at CDER. Computer technologies may be applied to INDs, ANDA, and antibiotic applications as well as to NDAs, the agency pointed out. The document solicits comments and suggestions regarding CANDAs by March 14, 1989. The guidance specifically requests input "that will help [FDA] develop an overall CANDA policy," as opposed to comments that "propose adoption of specific equipment, systems, computer programs, and services." CANDAs may be developed by the sponsor or by a third party, the agency noted. If the CANDA is contracted out to a third party, FDA said that sponsors should identify the developer of the CANDA during initial discussions with the agency. The guidance defines a CANDA as: "any method using computer technology to improve the transmission, storage, retrieval, and analysis of data submitted to FDA as part of the drug development and marketing approval process." Due to limited agency resources, reviewing divisions will provide "detailed consultation" on the development of CANDAs "only in the course of their ordinary regulatory discussions with sponsors," FDA said. The agency emphasized that "the reviewing divisions are not in a position to offer assistance directly to third party vendors who are not currently working with a sponsor involved in obtaining FDA marketing approval of a drug . . . (i.e., whose intention is to develop and market data processing methodology for use by drug sponsors)." Such third party vendors should contact Robert Bell, FDA said. Addressing speculation that computerized submissions may get a faster review at the agency than traditional hard copy NDAs, FDA maintained that the CANDA "will not influence the priority given to an application." During consultations with CDER, the drug sponsor should also be prepared to discuss: "general characteristics of the proposed application, including the methods and data files to be used"; "computer hardware requirements" and compatability with FDA equipment; computer software chosen; and "plans for CDER reviewer orientation and training," including "instructing reviewers in the use of the computer hardware, data file content and structure, and retrieval routines." The guidance adds that "sponsors should also be prepared to provide continuing technical support and advice to reviewing personnel."

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