The Food and Drug Administration (FDA) is proposing to amend its regulations concerning the format and content of the “Pregnancy”, “Labor and delivery”, and “Nursing mothers” subsections of the “Use in Specific Populations” section of the labeling for human prescription drug and biological products. The agency is proposing to require that labeling include a summary of the risks of using a drug during pregnancy and lactation and a discussion of the data supporting that summary. The labeling would also include relevant clinical information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy and/or lactation. The proposal would eliminate the current pregnancy categories A, B, C, D, and X. The “Labor and delivery” subsection would be eliminated because information on labor and delivery is included in the proposed “Pregnancy” subsection. The proposed rule is intended to create a consistent format for providing information about the effects of a drug on pregnancy and lactation that will be useful for decisionmaking by women of childbearing age and their health care providers.
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