JOURNAL ARTICLE
REVIEW
Add like
Add dislike
Add to saved papers

Effect of US Food and Drug Administration's Cardiovascular Safety Guidance on Diabetes Drug Development.

In 2008, the US Food and Drug Administration (FDA) issued guidance on the need for cardiovascular outcome trials to assess the safety of new diabetes medications. Using two large commercial databases, we evaluated the effect of the FDA's cardiovascular safety guidance on drug development for type 2 diabetes as well as a comparison group of drugs intended to treat other alimentary and metabolic conditions. The FDA's guidance was associated with a 31% differential decrease in the rate of diabetes drugs entering phase II trials, but the remaining drugs were significantly more likely to target novel biological pathways (72% of drugs had novel mechanisms after the guidance vs. 49% before the guidance). No differential changes were observed for phase I and phase III trials. There was no measurable improvement during the study period in glycemic efficacy among investigational products entering phase III trials. This research highlights how regulatory actions can impact pharmaceutical innovation.

Full text links

We have located links that may give you full text access.
Can't access the paper?
Try logging in through your university/institutional subscription. For a smoother one-click institutional access experience, please use our mobile app.

For the best experience, use the Read mobile app

Mobile app image

Get seemless 1-tap access through your institution/university

For the best experience, use the Read mobile app

All material on this website is protected by copyright, Copyright © 1994-2024 by WebMD LLC.
This website also contains material copyrighted by 3rd parties.

By using this service, you agree to our terms of use and privacy policy.

Your Privacy Choices Toggle icon

You can now claim free CME credits for this literature searchClaim now

Get seemless 1-tap access through your institution/university

For the best experience, use the Read mobile app