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’s Draft Agenda for the CFS/ME Patient Input Meeting

This article was originally published in RPM Report

Executive Summary

Here is a draft agenda made available by FDA ahead of the April 25-26 first-ever PDUFA V patient input workshop on chronic fatigue syndrome/myalgic encephalomyelitis. FDA notes that a final agenda will be made available a week before the meeting.

You may also be interested in...



FDA-CMS Parallel Review Pilot Will Be Extended; Drugs Not The Focus

CMS remains open to the idea of using parallel review (or, less formal parallel advice) for prescription drugs, but the current and future focus of the pilot program is likely to stay on devices and diagnostics.

Personalized Medicine Meets Payment Policy: MEDCAC Has “Low Confidence” In Most Cancer Tests

Genomic screening of tumor types may be the cutting edge in cancer treatment and a central component of the President’s vision for personalized medicine. But how much evidence is necessary to make insurance coverage for testing routine?

Looking Forward At FDA: Hamburg’s Farewell Notes Challenges; Califf’s First Remarks Focus on Pediatrics

FDA Commissioner Margaret Hamburg is leaving the agency on a high note – and taking the opportunity to urge stakeholders to avoid the temptation to push for changes that will “”weaken or undermine” the agency. Meanwhile, FDA's new Deputy Commissioner of Medical Products Robert Califf makes his first formal remarks in that role during a stakeholder meeting on pediatric research.

Topics

UsernamePublicRestriction

Register

LL1134044

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