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Executive Summary

SUPPLEMENTAL ANDAs: "FIRST IN-FIRST REVIEWED" POLICY EXCEPTIONS include giving "high priority" to the review of a labeling amendment, according to an FDA Division of Generic Drugs "Policy and Procedure Guide" issued May 22. Review of supplemental applications will continue on a first in-first reviewed basis except when "the only outstanding issues of an application that was previously processed as multiple supplements require an amendment which relates to labeling," the guide says. "If the chemistry portion of the review is otherwise complete and satisfactory, such an amendment should be considered as having a special high priority for review." The guide also notes that other exceptions would be made for "certain submissions accompanied by a request for expedited review that the office concurs in as per" the policy outlined in a previously issued guide ("The Pink Sheet" April 9, T&G-11). FDA pointed out that issuance of the guidance is a result of "allegations of preferential processing of reviews for firms that provided illegal gratuities to FDA reviewers and a supervisor." The guide notes that "an appropriate starting point for avoiding a recurrence of such problems is the statement of a clear policy for the division pertaining to the order in which reviews are initiated and pursued." In general, review priority for supplemental ANDAs and AADAs (abbreviated antibiotic drug applications) "is based on the date the application is received and filed by the division," the guide states. For resubmissions of supplemental applications "review priority is based on the date the resubmission is accepted (not) the date of the initial receipt of that supplemental application)." Once the review of a supplemental application begins, the guide says, "it should ordinarily be pursued to completion or to the greatest extent possible, before moving to the next review assignment in the queue." For example, the guide noted that when copies of drug master files (DMFs) must be requested, "the reviewer should pursue the review of all other aspects of the submission" while awaiting delivery. "Only in the continued absence of the DMFs should the reviewer go on to the next application on their printout." A separate guide describes the first in-first reviewed policy for original applications ("The Pink Sheet" March 19, T&G-2). In a May 15 memorandum to Office of Generic Drugs staff, Acting Director Bruce Burlington noted that "some reviewers may be reluctant to undertake expedited reviews or diverge from a strict 'first in-first reviewed' approach out of concern that if a complaint is voiced they may have to justify their action." Burlington stressed that "where such exceptions follow our established policy for exceptions, reviewers should be assured that they are not putting themselves at risk of being perceived as arbitrary." The guide also sets out policy for "minor" and "major" amendments that respond to action letters. '"Minor' amendments (those requiring not more than one hour to review) go into the reviewer's queue at 30 days, that is their review priority is set at 30 days less than the date of the oldest submission in the reviewer's work queue." Major amendments "go into the reviewer's queue at 120 days." Reports received from FDA field or headquarters units on methods validation and inspectional requests "are to be reviewed as soon after receipt by the reviewer as is convenient and not disruptive," the guidance says. Regarding labeling supplements, the guide says that the first in-first reviewed policy applies "only to a minority" of these changes. The agency has issued a separate guidance for labeling revisions.

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