NORD Submits Citizen's Petition to FDA Regarding Orphan Drug Reviews

I am proud to have joined the NORD board earlier this year. And I am particularly proud of the petition recently submitted to the FDA.

 

NORD's petition raises the collective voice of rare disorders regarding regulatory issues. Rare disorders present opportunities and challenges for the FDA. NORD's request for a statement of policy will provide guidance for this shared concern. Rare diseases have come of age and this policy will be critical if we are to develop treatments for over 30 million Americans whose lives are impacted by over 7,000 rare diseases.

 

Read the petition presented by NORD.

Views: 311

Comment

You need to be a member of PPMD Community to add comments!

Join PPMD Community

Comment by Peter on September 12, 2011 at 5:17pm
I think that in case of rare and fatal diseases the approach to register a drug should be much more flexible.The drug should be commercialized without completing long-run tests. Much more risk should be accepted.
Comment by RAKTIM SINGH on September 9, 2011 at 9:34am

 Thanks Pat for raising our concerns and presenting case on behalf of us. This petition raises very valid points. Your association with NORD and this petition will be an important milestone in our journey towards cure.

Need help using this community site? Visit Ning's Help Page.

Members

Events

© 2019   Created by PPMD.   Powered by

Badges  |  Report an Issue  |  Privacy Policy  |  Terms of Service