
01. Edit your pre issuance review audit online
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After the reviewers approve your plans, your permit goes into pre-issuance. During pre-issuance, staff checks your plans for approval stamps and notes. TheyRead more
(a) Applicant review. ODAFF may ask an applicant to review its permit for calculation and clerical errors or mistakes of fact or law before the permit is issued
These charts represent 1) original ANDAs and 2) ANDA prior approval supplements (PASs) for which FDA has issued review communications and/or taken an action.Read more