Revised ANDA Checklist from FDA

Recent changes to ANDA checklist has been issued by FDA, unfortunately this is not currently available on FDA website but I had a copy of this and hence thought I would share this with my fellow RA colleagues.

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:

1. 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)
2. 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;
3. 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).
4. 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).