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

Pradaxa Medicare Study: Observing a Slow Attitude Change at FDA on Observational Studies

This article was originally published in RPM Report

Executive Summary

CDER Deputy Director Bob Temple is a confirmed skeptic of the value of observational trial data to FDA’s regulatory decisions. A recent Medicare study on the bleeding risks associated with Boehringer-Ingelheim’s Pradaxa, however, confirmed an earlier position on the drug by FDA and meets with Temple’s approbation.

You may also be interested in...



Will Real-World Data Sway Course Of Novel Anticoagulant Market?

A wave of data to support use of novel anticoagulants in real-world settings was presented at the European Society of Cardiology Congress, but the question is whether this will alter the course of the market still dominated by warfarin and trailed by J&J/Bayer's Xarelto.

Reality Check For Real World Data: FDA’s Sentinel Network Enters “Production” Stage

FDA’s Sentinel drug safety surveillance network has completed an important transition, moving from “experimental” to “production stage” as a tool to help inform post-market safety decisions. Now the question is whether real-world data can be used in making efficacy decisions.

BI’s Pradaxa Gets Mixed Reviews In Postmarketing Studies

Two observational studies of Medicare patients reach different conclusions on Pradaxa bleeding rates, but FDA says risk/benefit profile of drug has not changed.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS079731

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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