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NDA/ANDA APPROVAL TIME CAN BE SHORTENED BY EARLY PLANT INSPECTIONS

Executive Summary

NDA/ANDA APPROVAL TIME CAN BE SHORTENED BY EARLY PLANT INSPECTIONS, Office of Compliance Director Daniel Michels advised a Manufacturing the Controls seminar held by the Proprietary Association (P-A) in Philadelphia Oct. 15. Manufacturers are being encouraged to request early FDA inspection of plants that will be manufacturing new drugs as part of an overall agency effort to speed up the review process, Michels noted. "It is not necessary for you to wait until somebody shows up to do a preapproval inspection," Michels explained. "In a number of instances" FDA has responded to the requests of firms and "looked at new facilities, new operations, new processes" before an NDA or ANDA has been approved, Michels reported. What this does, Michels stated, "is let you get a little bit of a lead on getting your NDA or ANDA approved." The compliance director maintained that, from both FDA's and industry's point of view, "there is more to be gained" by early agency review of new plants and processes "before you are actually ready to start producing product." With the emphasis on shortening approval times, Michels predicted that FDA "is going to be doing more pre-NDA/ANDA approval inspections." He also noted that Treatment IND applications will also pressure the agency to conduct early inspections. Michels noted that the new Treatment IND policy is also enhancing agency concern with GMP compliance for pilot plants. In conducting inspections of pilot plants recently, Michels noted that the agency has found several to be out of compliance with GMPs. "There is a good deal of work that needs to be done in pilot plant operations and the production of clinical drug products," he cautioned. "Compliance with GMPs in the production of clinical drug products is going to be more important as the Treatment IND process unfolds, and you need to be aware of it," the FDA official said. FDA compliance staffer Joel Davis told the P-A group that prompt submission of samples to the FDA laboratory for validation of ANDA methods is another step applicants can take to facilitate the approval process. "One of the problems that we have had is that when you are asked to submit those samples, very often an inordinate time period goes by before those samples reach the laboratory," Davis explained. "That creates a lot of problems within our laboratory, because we expect those samples, we gear up for the method, we dedicate the equipment, and then when the sample doesn't show, we loose the dedication of equipment and then have to reprioritize later."
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