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


Rare Disease Drugs Need Faster Development Track, Sen. Brownback Tells FDA

Executive Summary

Sen. Sam Brownback, R-Kansas, told FDA it should establish a second track for the development and approval of drugs for rare and neglected diseases

You may also be interested in...

Effectiveness Of Priority Review Voucher, Orphan Status Part Of Tropical Disease Hearing

September public hearing will continue FDA's look into rare and neglected disease drug development.

Carbaglu Does Not Set Precedent For Orphan Drugs To Skip Trials, FDA Says

FDA is not setting a precedent by considering Orphan Europe's orphan drug Carbaglu for approval without a clinical trial, FDA's Office of Drug Evaluation III Director Julie Beitz indicated after the Endocrine and Metabolic Drugs Advisory Committee's Jan. 13 vote for approval

A Rare Opportunity? FDA Orphan Products Head Makes The Case For More Big Pharma Investment In Rare Diseases

"Over the last 26 years, large pharmaceutical companies have missed an incredible opportunity," says Tim Coté, head of the Food & Drug Administration's Office of Orphan Product Development

Related Content





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