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

Orphan Drugs Warrant Flexibility On Clinical Pharmacology Data, FDA Panel Says

Executive Summary

FDA should use its regulatory flexibility to require fewer pre-approval clinical pharmacology studies, with increased emphasis on post-marketing studies and mandatory registries, to speed development of orphan drugs, the agency’s Advisory Committee for Pharmaceutical Science and Clinical Pharmacology said.

You may also be interested in...



Does The Orphan Drug Act Need A Facelift? Advocates Consider Changes

Rare disease advocates are wondering whether it may be time to strengthen the Orphan Drug Act and at least one organization is researching potential improvements that could be made to the pathway.

Does The Orphan Drug Act Need A Facelift? Advocates Consider Changes

Rare disease advocates are wondering whether it may be time to strengthen the Orphan Drug Act and at least one organization is researching potential improvements that could be made to the pathway.

PDUFA V Agreement Set In Four Areas, But Broad FDA/Industry Talks Continue

FDA and industry have reached agreement on four issues in the Prescription Drug User Fee Act reauthorization, including adjustments to risk-benefit policy and creation of a meta-analysis team.

Related Content

Topics

UsernamePublicRestriction

Register

OM010563

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