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


FDA’s Sentinel initiative

This article was originally published in The Tan Sheet

Executive Summary

FDA will tap Medicare Part D's large-scale claims database for the pilot phase of its Sentinel post-market drug safety surveillance initiative, Health and Human Services Secretary Mike Leavitt announced May 22. The Sentinel initiative aims to create a national electronic system for monitoring the safety of drugs and devices, and will also incorporate elements of FDA's Adverse Event Reporting system (1"The Tan Sheet" Feb. 20, 2006, p. 5). A 2white paper also released May 22 does not indicate when a full-scale network of participants will be ready, but notes the agency will start using Part D data as soon as practicable to launch the project...

You may also be interested in...

AERs To Go Online: Drug Safety Budget Proposal Funds Web Version

FDA is proposing increased drug safety funding to launch its web-accessible, second-generation Adverse Event Reporting System

Quick Listen: Scrip's Five Must-Know Things

In this week's podcast edition of Five Must-Know Things: Teva’s immunology biosimilar launches; Intra-Cellular’s promising depression data; Phase III sleep apnea win for Lilly’s tirzepatide; an interview with Viking’s CEO; and China looks to define innovative drugs.

No Korea-Originated New Drugs Approved Domestically In 2023

Notable new drug approvals in South Korea last year included Pfizer’s Tukysa, Genentech’s Columvi and BeiGene’s Tevimbra, but the tally did not include any domestically-originated products. Alzheimer’s disease therapy lecanemab may be on the horizon this year.


Latest Headlines
See All



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