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COMPUTERIZED NDAs: PMA URGES FDA TO CONTINUE ACCEPTING

Executive Summary

COMPUTERIZED NDAs: PMA URGES FDA TO CONTINUE ACCEPTING computer-assisted NDAs (CANDAs) from different systems. In March 1 comments, the Pharmaceutical Manufacturers Association said: "FDA must resist the temptation to decide prematurely upon an optimal technology before sufficient experience with different hardware/software configurations are obtained." The comments responded to an agency "guidance" on CANDA submissions, published in the Sept. 15 Federal Register. The guidance states that the filing of a CANDA is conditional on the reviewing division's willingness to accept the application ("The Pink Sheet" Sept. 19, p. 7), PMA noted. The association emphasized its concern that reviewers may refuse applications because they are unfamiliar with certain systems and thereby establish a de facto standard. "Just as FDA encourages drug sponsors to explore the use of CANDAs and to explore new systems and technologies," the association said, "PMA similarly encourages FDA to ensure that its reviewers are equally committed to accepting this diversity and working with drug sponsors to maximize their experiences with the variety current technology offers to both sponsors and reviewers in CANDA functionality." "At some point," PMA noted, "a decision will need to be made regarding a 'uniform approach' to a CANDA system." As a result, "it must be recognized that such a decision will ultimately be based upon prevailing technology at a specific point in time and based upon the ability of that technology to provide FDA reviewers with reasonable capabilities to fulfill their regulatory obligations." PMA noted that FDA's efforts to explore use of computers in the drug approval process has relied to date on "sponsors loaning computer equipment to FDA in order to support these experimental projects." The association offered to help resolve the "logistical difficulties" presented by that arrangement. "We recognize that FDA will likely need to structure and implement a mechanism to allow the agency readily to identify resident equipment, the source of that equipment, and the application associated with that equipment, PMA and its members will continue to assist FDA in these efforts."

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