FDA locks down post-approval pregnancy safety data framework

This FDA framework comes as significant knowledge gaps remain around the efficacy and safety of drugs in pregnancy and lactation. This framework comes as significant knowledge gaps remain around drug safety and efficacy in pregnancy. The FDA has issued a guidance detailing best practices for sponsors collecting post-marketing safety data on a drug in pregnant women. Credit: Viktor Gladkov / Shutterstock.com. The US Food and Drug Administration (FDA) has debuted its final industry guidance on collecting post-marketing safety data for both drugs and biologics in pregnant individuals. The framework, which aims to create pregnancy safety information that drugmakers can include…

Source: Clinical Trials Arena