Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format; Draft Guidance for Industry; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products--Content and Format." This draft guidance is intended to assist applicants in complying with the new content and format requirements in the Pregnancy, Lactation, and Females and Males of Reproductive Potential subsections of labeling for human prescription drug and biological products, as described in the final rule, Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling. The rule, which is being published concurrently with this draft guidance, is referred to as the "Pregnancy and Lactation Labeling Rule" (PLLR). The draft guidance will assist applicants in developing labeling for new products, revising existing labeling, and implementing the content and format requirements of the PLLR for human prescription drug and biological products.