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Executive Summary

ANDA NON-APPROVABLE LETTERS WILL BE ISSUED when chemistry reviews are concluded and "major deficiencies are identified" in lieu of a chemistry information letter, the Division of Generic Drugs noted in a Sept. 19 policy and procedure guide. The Generic Drugs Division said it is taking this step "in the interest of more timely processing of review actions." The purpose of issuing non-approvable letters in such cases, the guide states, is "to expedite the application review process by communicating to the applicants as soon as possible the specific deficiencies in their applications." The division said it "has chosen not to use the IR [chemistry information letter], preferring to limit correspondence on deficiencies to only those that meet the conditions for a final action and that 'stop' the clock." The guide explains that the division will "ordinarily issue non-approvable letters for original applications and supplements based solely on chemistry, manufacturing and controls deficiencies." Such non-approvable letters, FDA noted, "will issue even if one or more other review aspects normally necessary for a complete communications are fragmentary or otherwise not available, namely, bioequivalence, methods validation, sample analysis, microbiology consultation evaluations or establishment evaluations." The Generics Division will also include a provision in the non-approvable letters for chemistry deficiencies advising ANDA and AADA sponsors that other aspects of the submission have not been addressed, but could also result in citations or deficiencies. The guide explains that action letters will not issue "in the situation where the chemistry review has been completed yet no deficiencies have been identified and other reviews (field clearance, etc.) are pending." FDA said that applications, in this case, "will stay in a 'pending-review' status until the remaining reviews are received and letters to the applicants issue." The division said it will not issue non-approvable letters where a chemistry review identifies "only minor deficiencies and one or more other review aspects have not been received." In these cases, the branch CSO (consumer safety officer) or chemistry reviewer will usually outline the deficiencies by telephone and request appropriate amendments. The guide advises applicants who are notified of such deficiencies to note in their reply to the agency that it is for a "minor deficiency." Responses to minor deficiencies, FDA noted, "will ordinarily be treated as minor amendments for purposes of review-prioritization." Labeling deficiencies, the guide explains, are normally provided to the chemistry review branch and cited in non-approvable letters for chemistry deficiencies. The division pointed out, however, that it may not wait for the chemistry review to be completed in some circumstances -- for example, "when the labeling of the listed (pioneer) drug undergoes major revision following issuance of several ANDA/AADA non-approvable letters and amendments yet a few chemistry deficiencies remain unresolved." In such cases, the labeling reviewer "will ordinarily direct the applicant to start the process over, either citing the specific innovator insert as a reference or by providing detailed instructions for change."

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