Which labeling framework provides updates on pregnancy and lactation labeling in the U.S.?

• A. PLLR
• B. PREA
• C. BPCA
• D. FDAA

Answer: (D)

The updates to pregnancy and lactation labeling in the United States are provided by the Pregnancy and Lactation Labeling Rule (PLLR). This framework creates a dedicated, narrative-style format for presenting pregnancy and lactation information on drug labels, replacing older categories with a clear risk summary and data discussion. The PLLR was established under the FDA Amendments Act (FDAA), which gives FDA the authority to require labeling updates and postmarketing studies. The other terms relate to pediatric labeling—PREA and BPCA focus on pediatric studies and incentives—and while FDAA provides the legal authority, the actual mechanism that updates pregnancy and lactation information is the PLLR.