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 Expands Safety Signal Assessment With Mechanism-Based System

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA will work with MolecularHealth Inc. to adapt the company’s software system, which combines molecular data with clinical data, to allow mechanism-based assessment of side effects.

You may also be interested in...



Mini Sentinel Data Covers 126 Million Patients; FDA Weighing Potential Uses For Drug Industry

With the recent addition of claims data from two major insurance companies, the FDA postmarketing drug safety surveillance pilot project known as Mini Sentinel has already exceeded its statutory goal of gaining access to electronic health care data for 100 million individuals by July 12, 2012.

Biomarker Qualification Should Be Multi-Step Process, Regulators Say

U.S. and European regulations expect qualification of biomarkers for clinical use to be a multi-stage process that incrementally broadens a marker's application

FDA Prepares To Begin Search For Drug Safety Issues At Molecular Level

Combination of new science and technology could allow drug developers to identify molecular risk targets, much as they look for therapeutic targets, agency tells advisory panel.

Topics

UsernamePublicRestriction

Register

PS073759

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