FDA to Approve ANDAs on the Basis of Draft Labeling
The US Food and Drug Administration (FDA) on Monday said via guidance it will approve Abbreviated New Drug Applications (ANDAs) on the basis of draft labeling.
The guidance, which FDA is implementing without prior public comment because the agency says it's a "less burdensome policy that is consistent with public health," clarifies that the Office of Generic Drugs (OGD) will no longer require the submission of final printed labeling (FPL) in order to approve an ANDA.
The approval of ANDAs based on draft labeling, however, will occur only if the deficiencies in the draft labeling are of an editorial or minor nature, and that the labels meet other agreed-upon recommendations, FDA says.
The Switch
OGD previously requested FPL before approving ANDAs because FPL reflected an "accurate presentation of the layout, print size, color, prominence, and readability of a label," which allowed OGD to determine whether the labeling conformed to content and formatting requirements.
But as ANDA labeling submissions evolved, particularly with electronic versions, OGD found that draft electronic versions could enable an appropriate labeling review before a final printed version is produced.
As for the prescribing information and FDA-approved patient labeling, the draft version "should reflect the full content of the labeling as well as the planned ordering of the content of the labeling in order for OGD to make this determination," FDA says.
FDA also explains that for carton and container labeling, OGD reviews the labeling to ensure that, among other things, it is adequate from a safety perspective.
"This review includes an evaluation of formatting factors such as the colors used (e.g., to differentiate multiple strengths of the product), the font size and style used to present required information (e.g., the established name), and any other techniques used to ensure the required information is presented with appropriate prominence," FDA says. "Thus, draft versions of this labeling should reflect the content as well as an accurate representation of the layout, text size and style, color, and other formatting factors that will be used with the FPL."
FDA adds that this guidance from Monday supersedes the “Acceptability of Draft Labeling to Support a Tentative Approval” section of OGD’s August 4, 1993, letter to industry and also supersedes the statement in the preamble of FDA’s proposed rule, “Abbreviated New Drug Applications and 505(b)(2) Applications,”2 that “final printed labeling is required as a condition of approval [of ANDAs].”