Medtech Insight 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

FDA Pharmocogenomic Data Guidance To Be Finalized By Year-End

This article was originally published in The Gray Sheet

Executive Summary

FDA will issue a final guidance on pharmacogenomic data submissions later this year, Center for Drug Evaluation & Research Acting Director Steven Galson, MD, told the Biotechnology Industry Organization annual meeting in San Francisco

You may also be interested in...



Drug/Diagnostic Co-Development Guidance Should Be Flexible – Roche Exec

FDA draft guidance on co-development of drug/ diagnostic products likely will be released before 2005, according to the Center for Drug Evaluation & Research's Lawrence Lesko, PhD

Drug/Diagnostic Co-Development Guidance Should Be Flexible – Roche Exec

FDA draft guidance on co-development of drug/ diagnostic products likely will be released before 2005, according to the Center for Drug Evaluation & Research's Lawrence Lesko, PhD

Cancer Segment Likely First Market For Roche’s SynergysDx Program

Roche Diagnostics is anticipating that the drive to commercialize pharmacogenomic technology will create a need for coordinated drug and diagnostic premarket efforts, triggering increased demand for development partnerships between the two sectors

Latest Headlines
See All
UsernamePublicRestriction

Register

MT020385

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