Prescription medication use during pregnancy in the United States from 2011 to 2020: trends and safety evidence

O Mansour, RG Russo, L Straub, BT Bateman… - American journal of …, 2023 - Elsevier
Background Medication use during pregnancy has increased in the United States despite
the lack of safety data for many medications. Objective This study aimed to inform research …

Landscape review of global real‐world data sources for studying medication use in pregnancy and lactation that support regulatory decision making

K Davis, E Yost, J Brauneis, A Krumme… - … and Drug Safety, 2024 - Wiley Online Library
Purpose Most pregnant people take at least one medication during gestation or while
breastfeeding, however data are lacking on the safety of medication use in these …

A descriptive analysis of postmarketing requirement studies and clinical trials

L Choi, B Etchey, M Billings, C Lee… - … and Drug Safety, 2024 - Wiley Online Library
Abstract Purpose Under the Food and Drug Administration Amendments Act of 2007
(FDAAA), the FDA has the authority to require applicants to conduct postmarketing studies or …