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

Patient Community Is FDA’s “Guiding Light” On Acceptable Drug Risks

This article was originally published in The Pink Sheet Daily

Executive Summary

CDER’s Janet Woodcock says the community has the agency’s ear when it advocates new developments; cites need for an “adult conversation” in assessing when drugs should be made available to patients.

You may also be interested in...



FDA’s Patient-Focused Meetings: Round One Selections Include Diseases Broad And Rare

Breast and lung cancer, female sexual dysfunction and hemophilia are among 16 diseases that FDA will discuss with patients to get their perspective for drug development; additional diseases will be chosen in a future round.

ALS Patients Ask FDA To See Risk Their Way

An FDA panel got an earful on the review and regulation of drugs for amyotrophic lateral sclerosis Feb. 25 during a public hearing convened under the agency’s plan to involve patient networks in the regulatory process, particularly where it concerns lowering barriers to drug development for ALS.

ALS Drug Development Gets FDA Hearing, Could See Push For Surrogate Markers

The ALS Association says it worked with FDA to seek a public forum in which ALS patients can present their perspective on benefit/risk in development of drugs for their condition.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

OM014079

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