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

Regulatory Workaround, Not Statutory Changes, Better For Personalized Medicine Development, FDA Commissioner Hamburg Says

Executive Summary

FDA Commissioner Margaret Hamburg said that working within the current regulatory framework rather than seeking new statutory authority to address the development of drugs and accompanying diagnostic tests would be preferable to address personalized medicine questions at the agency

You may also be interested in...



Personalized Medicine Needs Personalized Advocacy To Advance, PhRMA Says

CEO Castellani says message has to be specifically tailored to payers, patient advocates and regulators.

FDA Aims For Flexibility In Upcoming Drug/Companion Diagnostic Guidance

FDA is trying to build flexibility into its drug/diagnostic co-development guidance to address variability in how and when therapeutics and companion diagnostics are developed

FDA Aims For Flexibility In Upcoming Drug/Companion Diagnostic Guidance

FDA is trying to build flexibility into its drug/diagnostic co-development guidance to address variability in how and when therapeutics and companion diagnostics are developed

Related Content

Topics

UsernamePublicRestriction

Register

PS052017

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