Revised ANDA Checklist FDA has revised the ANDA Checklist. In this checklist there are some new items that FDA will be looking for in its initial Completeness and Acceptability Review of ANDAs. Failure to include this information could result in a Refuse-to-Receive letter and a penalty of 25% of your ANDA user fee. The revised checklist includes the following new informational requirements and spells out more precisely what the Office of Generic Drug (OGD) reviewers will be looking for: The applicant is required to identify in the cover letter of the application whether the product is subject to a Risk Evaluation and Mitigation Strategy (REMS); A Label Comprehension Study is now required for Pharmacy Bulk Packages -injectable containers that are usually used in hospitals or admixture pharmacies that are typically not preserved and contain multiple doses of drug from which individual patient doses are extracted under aseptic conditions; A new characterization table for drug substances (see 3.2.S.3 in the checklist) to provide chemical name, Code #, chemical structure, process/degradation impurity, and the source/mechanism of the impurity or degradation product (see 3.2.S.3 of the checklist). Information is now required on the justification of proposed specification provided in tabular form (see 3.2.S.4.5 of the checklist). The same tabular format is being requested for impurity information for the drug product (see 3.2.P.5.5 of the checklist). Download the checklist here Posted Yesterday by Uday Shetty Labels: ANDA
Posted on: Sun, 16 Mar 2014 15:23:22 +0000
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