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Guidance on Draft Labeling to Support ANDAs


Federal Register Notice: FDA is making available a guidance for industry entitled Acceptability of Draft Labeling to Support ANDA Approval. It provides recommendations and information related to the submission of proposed labeling with ANDAs. It explains FDA’s interpretation of the regulatory provision related to submission of copies of applicants’ proposed labeling and clarifies that FDA’s Office of Generic Drugs will accept draft labeling and does not require the submission of final printed labeling in order to approve an ANDA. To download this guidance, click here. To view this notice, click here.