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Executive Summary

ANDA SUITABILITY PETITION RESPONSE BACKLOG: BY 1986 the agency should be able to meet the 90-day statutory requirement for petition responses, Office of Drug Standards Deputy Director James Morrison predicted at the Regulatory Affairs Professionals Society annual meeting in Washington, D.C. Sept. 19. Acknowledging that FDA has not been meeting the statutory requirement under the Waxman/Hatch law of responding to the petitions within 90 days, Morrison said: "I believe that we will have everything within 90 days hopefully by the end of the year and if we don't meet that, we're going to take another hard look at the system." Morrison told the meeting that currently "85 or 90" ANDA suitability petitions are pending at FDA, 65 of which are already past the 90-day statutory response requirement. Approximately 20 ANDA suitability petitions have received responses since enactment of the ANDA/patent restoration law, Morrison reported. FDA staff should have more time for the petitions now that the "paper" NDA conversions to ANDAs are under control, Morrison said. "You have to remember that the people who prepared the staff work on the petitions are the same people who are handling the ANDAs," he noted. FDA's first priorities were to get "the bolus of ANDAs out and running," Morrison observed. Morrison told the meeting that suitability petitions are now beginning to clear FDA more quickly. "I believe we're seeing for signature many more petitions than what we were seeing before," Morrison said, "and I think that there is enough in the pipeline right now that I could say pretty safely in the next month or two you'll be seeing substantial numbers ]of petitions being answered[ -- probably more than what you've seen so far."

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