Related Experiment Video
Updated: Apr 25, 2026

Using Chronic Social Stress to Model Postpartum Depression in Lactating Rodents
Published on: June 10, 2013
Opportunities and Challenges to Leveraging Real-World Data for Post-Market Safety Studies in Pregnancy and Lactation:
Carla Rodriguez-Watson1, Kaylan Ware1, Joy C Eckert1
1Reagan-Udall Foundation for the Food and Drug Administration, Washington, District of Columbia, USA.
Abstract:
This proceeding summarizes a meeting hosted by the Reagan-Udall Foundation for the Food and Drug Administration (FDA) (FDA Foundation) to understand the current use of and evidence for approaches that leverage real-world data (RWD) sources beyond registries to assess post-market drug safety studies in pregnant and lactating persons. Participants represented a wide breadth of expertise, including drug manufacturers, regulators, academic researchers, and health care providers and insurers. Participants reviewed the state of the science and developed solutions to advance the use of RWD to address limitations posed by traditional product registries, such as long timeframes and single-arm study design.
Related Concept Videos
Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Preclinical Development: Overview
Clinical Trials
There are four phases in a clinical trial. A phase one...
Toxicity Testing in Animals
Clinical Trials: Overview

