Navigation Links
NORD Calls FDA Action 'An Important Advance for Patients'
Date:2/25/2010

WASHINGTON, Feb. 25 /PRNewswire-USNewswire/ -- Peter L. Saltonstall, president and CEO of the National Organization for Rare Disorders (NORD), today said the Food and Drug Administration's (FDA) announcement that it has created a new position—Associate Director for Rare Diseases—in the agency's Center for Drug Evaluation and Research's (CDER) Office of New Drugs (OND) represents an important advance for patients with rare diseases.

"NORD asked FDA to create a new position within CDER to provide a focal point for the approval of new orphan drugs, and to supplement the support that orphan products receive from the Commissioner's office," Saltonstall said.  "We believe the creation of this new office reaffirms and expands FDA's commitment to facilitate the development and approval of safe and effective drugs for Americans with rare diseases."

Dr. Anne Pariser has been selected as the new Acting Associate Director for Rare Diseases and the agency said it will move quickly to fill the position on a permanent basis.  Dr. Pariser will report to the Director of the Office of New Drugs, Dr. John Jenkins.

"NORD has met with Dr. Pariser and her commitment to advancing the availability of safe and effective new drugs for rare diseases is clear," Saltonstall said.  "I especially want to thank Dr. Janet Woodcock, the Center's director, and Dr. Jenkins for their commitment to orphan products.  NORD also works closely with Dr. Tim Cote, and the staff of FDA's Office of Orphan Products Development, and we appreciate their commitment to the rare disease community."

Drs. Woodcock, Jenkins and Cote participated in NORD's Partners in Progress Summit last May and have met several times with NORD to discuss how to facilitate orphan drug development.

The FDA said that the Associate Director for Rare Diseases will serve as CDER's "focal point to the rare disease drug development community and assist stakeholders and developers of drug and biologic products in navigating the complex regulatory requirements for bringing safe and effective treatments to patients in need."

The Associate Director will also coordinate an initiative to develop CDER policies and procedures for the review and approval of treatments for rare diseases.  An important focus of this new initiative, according to FDA, will be to ensure collaboration among scientists and clinicians throughout CDER to help develop and bring to market new treatments for patients with rare diseases.

"Approximately 15 million Americans currently have rare diseases for which there is no treatment," Saltonstall said.  "One of NORD's primary missions is helping to fine-tune and accelerate the process of developing new treatments and evaluating their safety and efficacy.  We're very happy with FDA's announcement of the establishment of this position, which we view as a direct response to our advocacy."

SOURCE National Organization for Rare Disorders (NORD)

Back to top

RELATED LINKS
http://www.rarediseases.org

'/>"/>

SOURCE National Organization for Rare Disorders (NORD)
Copyright©2010 PR Newswire.
All rights reserved

Related medicine news :

1. Broad-based group of physicians calls for improvement in stroke treatment
2. Virginia Tech Review Panel Calls For Reform of Mental Health Treatment Law
3. HIDA Calls for Scrutiny of Group Purchasing Organization Distributor Fee Structure
4. Fairbank Farms Voluntarily Recalls 85% Ground Round Beef Patties Sold Fresh from Shaws Due to Possible Health Risk
5. Nuvelo Announces Upcoming Conference Calls, Webcasts and Conference Participation
6. AOA President Calls on Congress to Reauthorize SCHIP and Take Action to Ensure Health Care Coverage for All Americans
7. Center for Health Transformation Founder Newt Gingrich Calls on Congress to Pass a Clean SCHIP Six-Month Extension
8. Catholic Charities USA Calls on Congress and the President to Protect the Health of Children; Urges President Not to Veto Vitally Important Bill
9. Health IT Now! Coalition Calls on Congress to Pass Health Information Technology Legislation This Year
10. AARP Calls on Governor Schwarzenegger to Discourage Veto of SCHIP Expansion Bill
11. AARP Maryland Calls on President Bush Not to Veto SCHIP
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2017)... ... June 23, 2017 , ... Yesterday, U.S. ... healthcare bill to repeal and replace the Affordable Care Act (ACA). Like the ... significant cuts to Medicaid, a public health insurance program for low-income children, pregnant ...
(Date:6/23/2017)... ... June 23, 2017 , ... Everybody has their own ... others prefer to read it, and some people don't like it at all. FindaTopDoc ... what they found: , Erotic literature can give readers a taste of their deepest, ...
(Date:6/23/2017)... ... ... 21 Middle East and South Asia Leaders Selected as Eisenhower Fellows ... civil society in 11 countries across the Middle East and South Asia to embark ... of knowledge and ideas with the leading minds in their fields. , For ...
(Date:6/23/2017)... ... 23, 2017 , ... Ulster University, Magee Campus in Northern Ireland is hosting ... pm to present to graduate students exciting new and innovative hope research based on ... by The Health Improvement Service of the Western Health & Social Care Trust (WHSCT) ...
(Date:6/23/2017)... ... June 23, 2017 , ... Moore ... Houston area with access to asset protection and financial planning services, is teaming ... at improving the lives of children with cancer and other chronic diseases. , ...
Breaking Medicine News(10 mins):
(Date:6/14/2017)... 2017  ivWatch LLC, a medical device company focused ... therapy, is pleased to announce it was the Bronze ... Supplies and Equipment at the 2017 Medical Design Excellence ... industry. The award was presented by Medical Device and ... in New York during MD&M ...
(Date:6/13/2017)... -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a ... Food and Drug Administration (FDA) has notified the Company that ... Zhejiang, China manufacturing facility has been ... clearance of the Warning Letter related to our ... of the progress we have made in our ongoing quality ...
(Date:6/10/2017)... , June 9, 2017  Shane K. Burchfield, DPM, is recognized ... excellence as a Podiatrist in Alabama . ... Family First Foot Care. He brings over 20 years of experience, ... management and healthcare, to his role. ... Care, PC is pleased to welcome you to his ...
Breaking Medicine Technology: