FDA to accept draft labeling to support ANDA approvals

The US Food and Drug Administration yesterday displayed a notice in the Federal Register announcing the availability of a guidance for industry, titled Acceptability of Draft Labeling to Support ANDA Approval.

This final guidance clarifies that the FDA will approve Abbreviated New Drug Applications (ANDAs) on the basis of draft labeling, provided the agency is able to determine that the labeling complies with the applicable requirements based on the draft version. If so, applicants do not need to submit final printed labeling (FPL) in order to receive approval.

As ANDA labeling submissions have evolved over time, particularly with respect to the submission of electronic versions of labeling, the FDA’s Office of Generic Drugs (OGD) has found that draft labeling can enable an appropriate labeling review before a final printed version is produced.