Europe sees delivery challenges ahead on Alzheimer's therapies

VialsandpackagingforLeqembi,anewAlzheimer'smedicationapprovedintheU.S.,butnotyetinEurope.Illustratio RubyWallauforSTATModernachairmanNoubarAfeyanexudedstarpowerearlierthismonthashecommandedthespotlight




Wikipedia

author:leisure time    Page View:7191
Pregnancy and clinical trials
Adobe

The FDA has taken a big step in encouraging drug companies to include pregnant women in clinical trials, issuing a draft guidance outlining how to do so safely and ethically.

Nearly 4 million women in the U.S. give birth each year, but few drugs have been approved as safe and effective to use during pregnancy. The new guidance aims to help drug companies address those information gaps “through judicious inclusion of pregnant women in clinical trials and careful attention to potential fetal risk.”

advertisement

Experts say it’s a sign of progress on an issue that’s long plagued pregnant women and their physicians.

Get unlimited access to award-winning journalism and exclusive events.

Subscribe Log In