Pink Sheet is part 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

UsernamePublicRestriction

FDA Plans To Add Specifics To Statistical Part Of Antidiabetics CV Guidance

Executive Summary

FDA expects to make changes to its final guidance on evaluating cardiovascular risk for new type 2 diabetes drugs based on the experience gained from sponsors' implementation of the guidance

You may also be interested in...



Glycemic Control Not Enough For New Diabetes Drugs, Roche Exec Says

Sponsors must move beyond glycemic control if they want any new therapy for type 2 diabetes to be commercially viable, according to a Roche executive.

Diabetes CV Studies Spur Questions On Statistical Methods, Data Integrity

The need to conduct cardiovascular safety assessments for new type 2 diabetes drugs has raised concerns within FDA and industry about statistical methods, data confidentiality and blinding for CV outcomes studies.

Glycemic Control Not Enough For New Diabetes Drugs, Roche Exec Says

Sponsors must move beyond glycemic control if they want any new therapy for type 2 diabetes to be commercially viable, according to a Roche executive.

Related Content

Topics

UsernamePublicRestriction

Register

PS052417

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

Cancel