FDA to Accept Draft Labeling to Support Abbreviated New Drug Application Approvals

The FDA today displayed a notice in the Federal Register announcing the availability of a guidance for industry, entitledAcceptability 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 we are 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.

OGD developed this guidance, in part, in response to requests from industry to approve ANDAs based on draft labeling. Also, OGD continuously seeks ways improve its business practices, and this practice will help improve the efficiency of the Agency’s ANDA review process.

Although this guidance is for immediate implementation, the public may still submit electronic comments tohttp://www.regulations.gov.