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FDA GENERICS DIVISION WILL CRACK DOWN ON INCOMPLETE ANDAs

Executive Summary

FDA GENERICS DIVISION WILL CRACK DOWN ON INCOMPLETE ANDAs and responses to deficiency letters under a new policy that went into effect the week of May 14-18. The division will no longer file applications unless they are complete and "approvable" ANDAs. The division sent out its first round of letters to companies last week refusing to file incomplete ANDAs as well as "nonapprovable" letters for deficient submissions. The agency is expected to issue a "policy and procedure guide" on the subject. FDA says it can no longer "afford the luxury" of doing partial reviews for generic firms. In the past, companies have regularly submitted incomplete applications simply to enter the review queue and start the time clock. In order for the division to officially file an ANDA, the submitting company must provide all data for approvability. Before filing an ANDA, FDA wants: proper patent certification; information that shows the generic drug is the same as the listed drug; three months accelerated stability data; completed batch records on batches from stability tests and biostudies; and appropriate format. According to the agency, these are among the items most often found to be deficient in applications. In addition, responses to deficiency letters must answer all points addressed by the agency, FDA said. If a response is incomplete, the ANDA will be found to be deficient and the division will immediately issue a nonapprovable letter to the company. The nonapprovable letter will address what amendments should be made to the application to continue FDA consideration of the ANDA. Furthermore, FDA will begin a retoractive assessment of all pending ANDAs once it has examined recent submissions. Although the agency cannot refuse ANDAs currently on file and awaiting review, the division may take some action, possibly a nonapprovable letter, against those ANDAs that are still incomplete. Therefore, the agency said, firms should look at their submissions and quickly address any deficiencies. In addition, if companies are no longer interested in particular ANDAs, they will be asked to withdraw the submissions in order to help the agency clear up its files. As part of a broader effort to standardize the ANDA review process following the generic scandal, the agency recently announced that it is tightening standards for expedited review of ANDA and AADA supplements ("The Pink Sheet" April 9, T&G-11).
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