Global Regulatory Intelligence
Log in |  Register

Login to your account

Username *
Password *
Remember Me

Create an account

Registering to our Regulatory Updates easy andis should only
take few minutes. To begin, enter your email enter your email
address below so we can check to see if it is already existing
in our records. Your email address will also be used as your
user name when you log in.

Fields marked with an asterisk (*) are required.
Name *
Username *
Password *
Verify password *
Email *
Verify email *
Captcha *
Reload Captcha

USA: FDA Issues Revised ICH Risk-Benefit Submission Guidance

Thursday, July 27, 2017: The United States Food & Drug Administration (FDA) issued a revised version of its ICH-developed guidance on completing the clinical overview section of the Common Technical Document, including more details on risk-benefit submissions.

The guidance, known as M4E(R2), lists what sponsors should consider when describing risks and benefits, but does not specify a particular industry approach for completing assessments.

An ICH working group said the section of the CTD weighing benefits and risks — section 2.5.6, which also includes information on therapeutic context — should succinctly describe the sponsor’s thought process, but not present new data.

More Details
© 2016 MakroCare. All Rights Reserved.
  Privacy policy