Characterization of the US Food and Drug Administration Post‐Marketing Commitments and Requirements for Pregnancy and Lactation

C Avachat, IR Younis… - Clinical Pharmacology & …, 2023 - Wiley Online Library
Enactment of the US Food and Drug Administration Amendments Act (FDAAA) in 2007 and
the Pregnancy and Lactation Labeling Rule (PLLR) in 2015 are important milestones giving …