BCIQ Profiles

Company Profile Report

CVOT damage in diabetes

How FDA’s CVOT guidance has affected diabetes drug development

As FDA reconsiders its requirement for cardiovascular outcomes trials of new diabetes candidates, it’s clear that the development of new therapies has slowed since it was implemented.

In December 2008, FDA issued guidance requiring diabetes companies to show in pre-market studies that new drug candidates do not increase cardiovascular risk by more than 80%, and to

Read the full 563 word article

How to gain access

Continue reading with a
two-week free trial.