FDA Releases Guidance on Labeling

FDA issued guidance on Oct. 6, 2015 providing the agency’s recommendations for submitting proposed labeling with abbreviated new drug applications (ANDAs) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 Code of Federal Regulations (CFR) 314.94(a)(8). The guidance is directed at applicants submitting ANDAs under section 505(j) of the FD&C Act to the Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research (CDER).

In the guidance, FDA explains the agency’s “interpretation of the regulatory provision related to the submission of copies of applicants’ proposed labeling in ANDAs and clarifies that OGD will accept draft labeling and does not require the submission of final printed labeling (FPL) in order to approve an ANDA.”  The guidance 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,” that “final printed labeling is required as a condition of approval [of ANDAs].”