FDA recently announced the approval of the Acceptability of Draft Labeling to Support ANDA Approval guidance. This new guidance states that it is no longer required to submit a final printed label (FPL) to the Office of Generic Drugs in order to approve Abbreviated New Drug Applications (ANDAs).
Previously, the Office of Generic Drugs (OGD) required the submission of FPL because of the accurate layout and design specifications that accompany it in regards to formatting. With electronic submissions becoming more prevalent, the OGD was able to approve labeling review through electronic versions. All drafts must reflect the correct formatting factors, such as colors, font, layout, and information, in order to be considered for approval.
For more information, read Zachary Brennan’s article on RAPS.org. Need help with filing an ANDA regulatory submission? Contact us.