In a Federal Register (FR) Notice today (here) , FDA has indicated that a long-held practice of requiring the submission of actual or printers proof of final printed labeling (FPL) will no longer be required for ANDA approval, and that OGD will accept draft labeling for approval purposes. The requirement for the submission of FPL has been around even prior to the Hatch-Waxman Amendments of 1984.
The FR notice announces the availability of the final Guidance for Industry Acceptability of Draft Labeling to Support ANDA Approval (here). The change will go into effect immediately without going through a draft stage because this is a provision that will reduce the regulatory burden on industry and is consistent with the public health focus of the Food and Drug Administration. Comments can still be submitted by the generic industry to the docket cited in the FR notice.
FDA notes that “[g]iven changes in submission practices and the applicable regulations over time, OGD is clarifying that it will approve ANDAs on the basis of draft labeling, provided that OGD is able to make a determination that the draft labeling complies with applicable requirements (other than editorial or similar minor deficiencies).” In reading this, it is clear that your draft labeling should be pretty close to your FPL and there should be no issues.
Even though previous Agency Guidance (and even a Final Rule) stated that OGD would not approve an ANDA without FPL, FDA states that “[u]pon further consideration of the relevant statutory and regulatory provisions, FDA has determined that an ANDA may be approved on the basis of draft labeling, provided that the only deficiencies in the draft labeling are of an editorial or similarly minor nature, and the draft labeling meets the recommendations” outlined in this new guidance document.
Draft labeling of the package insert and patient labeling is fairly straightforward. OGD’s prior preapproval requirement for FPL centered mostly on container and packaging labels to assure that layouts, fonts, colors, and other general formatting provisions did not impact the safety of the product (e.g., readability, prevent potential medication errors). OGD acknowledges that current available technology has evolved to permit this review of draft labeling in lieu of FPL. So as long as the draft labeling submitted is sufficient to address these types of issues, OGD is happy with that. In addition, this will improve potential approval times, as FPL will not be the last thing holding up approval. The New Drugs side of the house typically approves its NDAs based on draft labeling and permit submission of FPL within a certain period post-approval. Now ANDAs and NDA will be on the same footing.
