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

20 Is The Loneliest Number: FDA Disease Meeting Schedule Leaves Some Worried About Exclusion

This article was originally published in The Pink Sheet Daily

Executive Summary

Conflict among groups with conditions both included and not included in the preliminary list of public meeting topics prompts FDA to reiterate that the diseases will be selected because better clinical measures are needed, not because the agency will prioritize them over others.

You may also be interested in...



FDA Ends Regularly Scheduled Patient-Focused Drug Development Meetings

After conducting 24 disease-focused meetings in five years, FDA moving to next phase of patient interaction under new user fee cycle.

Diabetes Endpoints, CV Requirements Get Special Handling At FDA-Patient Meeting

FDA solves citizen petition with first-of-its-kind virtual patient meeting; diabetes group now hopes trifecta of requests will make it from Commissioner’s Office to top CDER officials.

FDA Casts Wide Net For Patient-Focused Meeting Topics

Just a few slots remain under the agency’s original commitment under the PDUFA program, but the patient-engagement efforts appear highly valuable to FDA and industry alike.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS073402

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