For those of you that may have missed the January 2014 revision of the ANDA Checklist (last revised was 3rd quarter, October 2013), 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 (here) includes the following new informational requirements, or at least spells out more precisely what the Office of Generic Drug (OGD) reviewers will be looking for:
- OGD is now asking for the applicant to identify in the cover letter of the application whether the product is subject to a Risk Evaluation and Mitigation Strategy (REMS).
- Here is a big one – 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 ,usually within a defined short period of time), OGD will now expect to see a Label Comprehension Study – at least that is what the listing in the checklist says; however, when accessing the web link, there is a series of questions that must be evaluated in the filing review of such an application. Let’s hope that is all that this means (see 188.8.131.52 in the checklist).
- OGD is proposing 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).
- OGD also wants information 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).
That’s it for now – so begin updating your yet-to-be-submitted ANDAs so OGD won’t question how generic firms keep getting it wrong time after time! And for those 30 ANDAs you submitted that are still in a 6+ month queue for Completeness and Acceptability Review – Just hope you don’t get an R-T-R letter!