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
UsernamePublicRestriction

FDA Cancer Endpoint Guidance Abandons Placebos, Moves Beyond Survival

Executive Summary

FDA's final guidance on cancer endpoints has dropped a discussion on clinical trial designs that provide no treatment or use a placebo control

You may also be interested in...



Otsuka Busulfex's Overall Survival Claim Does Not Survive CDER Advertising Scrutiny

Statistical analyses based on pivotal trial data and used to promote a drug must prove what they purport to prove, FDA's Office of Prescription Drug Promotion says in an NOV letter to Otsuka over a website for the leukemia drug Busulfex (busulfan).

Panel Accepts FDA's Statistical Take On Micardis, Recommends Limited Use

FDA's Cardiovascular and Renal Drugs Advisory Committee sided with FDA's more conservative statistical analysis of Boehringer Ingelheim's Micardis, rejecting the company's claim that telmisartan demonstrated non-inferiority to ramipril in a pivotal trial

Panel Accepts FDA's Statistical Take On Micardis, Recommends Limited Use

FDA's Cardiovascular and Renal Drugs Advisory Committee sided with FDA's more conservative statistical analysis of Boehringer Ingelheim's Micardis, rejecting the company's claim that telmisartan demonstrated non-inferiority to ramipril in a pivotal trial

Related Content

UsernamePublicRestriction

Register

ID1132956

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