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Executive Summary

FDA "NOT APPROVABLE LETTERS" MAY FOLLOW PRE-APPROVAL INSPECTIONS that find facilities listed in a submission are "physically incapable of performing their designated function," Center for Drug Evaluation and Research Director Carl Peck, MD, stated in a June 19 letter to industry. The "Dear Applicant" letter currently is being sent to all sponsors of NDA or ANDA submissions. The agency is "making every effort to complete our review and pre-approval inspections in as timely a manner as possible," the letter says, but notes that the reason most often cited by pre- approval reviewers for delays is facilities and companies that are neither ready nor capable of properly handling an approved drug. "Lack of capability or readiness on the part of applicants and their vendors, suppliers, or contract manufacturers is the deficiency most frequently identified by our field offices in the pre-approval inspection program," the letter states. Applicants will have 60 days to review submissions and withdraw any "request for use of any facilities that have been described in the submission that are not capable of, or intended to be used in, producing the product for which the application is submitted," or face the possibility of a not approvable letter. Firms may use supplemental filings for the facilities when they are properly equipped, the letter says. The June 19 letter follows the March release of data from the first year of the pre-approval inspection program. Those data, as reported by FDA Mid-Atlantic Region Assistant Director Joseph Phillips, show that of 74 field inspections that recommended delaying NDA approval, 33 were because a sponsor listed an unprepared facility. Overall, the field recommended delays for 48% of NDAs and 46% of ANDAs ("The Pink Sheet" March 18, p. 6). Two examples of unprepared facilities inspected by FDA are cited in the letter. "In one case, an application contained a total of seven packaging sites requiring inspection, of which at least two were found to be lacking packaging equipment. In other instances, listed suppliers of raw materials were found not to have the necessary facilities or ability to supply the designated materials." Peck also chides companies for wasting agency reviewers time at more than one facility. "The time spent on facilities listed as alternative sites, but without such capability, only exacerbates our difficulties in the timely completion of reviews and inspections," the letter states.

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