Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Surveying the Landscape for Active Surveillance

This article was originally published in RPM Report

Executive Summary

The transition away from spontaneous adverse event reporting systems to real-time active surveillance is under way, but far from complete. Alan Goldhammer, the former head of regulatory affairs at the Pharmaceutical Research & Manufacturers of America trade association, surveys the landscape of active surveillance activities.

You may also be interested in...



Forget DTC; Get Ready for DFC: Using Social Media to Detect Safety Signals Direct From Consumers

The past decade has witnessed the importance of DTC pharma messages. With social media tracking and internet search signal detection, is the US at the edge of a DFC era? Will safety signals scraped from internet inquiries and social media conversations be the next wave source of drug safety concerns? A special subcommittee of FDA’s Science Board released a report at the beginning of May that advises FDA to pay attention to the opportunities from new media for picking up drug safety signals.

Bristol-Myers Squibb/AstraZeneca Onglyza is Guinea Pig for FDA Mini-Sentinel Post-Market Surveillance

FDA’s Congressionally-mandated active surveillance system, Sentinel, is ready for shakedown cruises in 2011. One of the first projects will be a close examination of real-world experience and cardiovascular events associated with saxagliptin. That’s a dubious distinction for BMS/AZ, the co-marketers of Onglyza–but it also sets up a new dynamic that all sponsors should watch.

Undermining the Foundation: High Stakes in Fight Over Reagan-Udall

The Reagan-Udall Foundation is the one piece of the FDA drug safety law enacted in 2007 that both FDA and industry are excited about. Congressional appropriators, however, have serious concerns. The stakes are higher than they seem: in the short run, the Critical Path and active surveillance systems may depend on the foundation. In the long run, the question is whether industry has any say in the evolution of regulation.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS080751

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