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Guidance on Pregnancy/Lactation Labeling for Drugs/Biologics

12/04/2014

Federal Register Notice: FDA is making available a draft guidance for industry entitled Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format. It is intended to assist applicants in complying with the new content and format requirements in the labeling subsections 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. To download this guidance, click here. To view this notice, click here.

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