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Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format; Draft Guidance for Industry; Availability

Resumo

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products--Content and Format." This draft guidance is intended to assist applicants in complying with the content and format requirements of the Pregnancy, Lactation, and Females and Males of Reproductive Potential subsections of labeling for human prescription drug and biological products. This draft guidance revises the draft guidance issued in December 2014. This revision provides clarification and additional information on recommendations to applicants submitting new drug applications (NDAs), biologics license applications (BLAs) (for biological products that are regulated as drugs), and efficacy supplements to approved NDAs or BLAs.