In Vivo is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


The Inevitable Outcome: Diabetes Safety Model Expands To Weight Loss…And Beyond?

Executive Summary

The cardiovascular outcomes standard used for diabetes drugs since 2008 is moving to weight loss. That is important in itself, but also for what it says about the lessons FDA has taken from the diabetes experience – and what it might mean about regulatory expectations for other chronic drug classes in the future.


Related Content

FDA Drug Shortage Staff Gets Higher Profile As New Reporting Requirements Begin
Patient Advocacy 3.0: Outreach Stretches to First Stages of Regulatory Development
CV Risk Assessment For All Obesity Drugs Seems Inevitable Pre-Approval Requirement
Regulatory Innovation: A Dialogue (Part II)
Just a Minute: The Final Step in Advisory Committee Process
A Tale of Two Drugs: Meridia and Avandia, and the Issues that Separated Them
Weighing the Regulatory Climate: Qnexa and the New Approval Model
FDA Will Soon Finalize Obesity Guidance, May Tackle CV Safety Separately


Related Companies




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts