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

Rare Disease Improvements Planned Soon, And Up To Five Years From Now

Executive Summary

FDA has short- and long-term plans to improve its rare disease program under PDUFA V, and next month the agency will continue its efforts to boost drug development in the sector.

You may also be interested in...



Draft Guidances For 2013 Will Grapple With Biosimilars, Track and Trace, Compounding

FDA’s Center for Drug Evaluation and Research plans to publish more than 50 new and revised draft guidances this calendar year.

Orphan Drug Safety: FDA Asks How Much Pre-Approval Data Is Enough?

Agency's Advisory Committee for Pharmaceutical Science and Clinical Pharmacology will be asked to weigh pre-approval data requirements and discuss innovative approaches to boosting drug development for rare diseases at its March 2 meeting.

With Federal Dollars Scarce, FDA May Fundraise For Regulatory Science Initiative

Industry and other federal agencies could end up helping fund Commissioner Margaret Hamburg’s Regulatory Science Initiative, as FDA searches for money outside the appropriations process.

Related Content

Topics

UsernamePublicRestriction

Register

PS053101

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