Pink Sheet is part of the Business Intelligence Division 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


Orphan Drug Reviews: Industry Wants FDA To Move Out Of Its Comfort Zone

Executive Summary

FDA may have to exit its drug review comfort zone and accept more trials outside the classic double-blind, placebo-controlled realm to promote more orphan drug development, industry and advocacy organizations told the agency

Related Content

Woodcock Says Blowing Up Orphan Drug Act Not Advisable In Current Climate
FDA Must Codify Flexibility For Rare Diseases, Coté Says As He Moves To NORD
Orphan Drugs Need Easier, Speedier Approval, Not More Exclusivity, CEO Says
Does The Orphan Drug Act Need A Facelift? Advocates Consider Changes
FDA Approval Via "Living License" Gaining Backers, But Major Players Not Among Them
FDA To Offer Reviewers Rare Disease Training; Patient Groups Want Separate ODE
User Fee Discussions Include Funding Parts Of FDA Regulatory Science Plan
Orphan Drug Incentives Would Go Further Than Regulatory Reform - Reardan
Biomarker Guidance To Encompass More Than Biomarkers, FDA Says
Biomarker Guidance To Encompass More Than Biomarkers, FDA Says





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