Do OEL Fastrac monographs include the pregnancy category?

As of December 3rd, 2018, OEL Fastrac monographs either newly created or revised will no longer include the FDA pregnancy category.

This is because on December 4, 2014 the U.S. Food and Drug  Administration (FDA) passed a new rule to implement new labeling requirements for pregnancy and lactation to  take effect June  2015. See link to article below.

Federal Register Final Rule

Draft Guidance

Did this answer your question? Thanks for the feedback There was a problem submitting your feedback. Please try again later.

Still need help? Contact Us Contact Us