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:10/13/2017)... ... October 13, 2017 , ... ... communities in the greater Dallas, Miami, and Raleigh regions, is organizing an extended ... overcome a rare and deadly chromosome abnormality. , After struggling since birth with ...
(Date:10/13/2017)... , ... October 13, 2017 , ... ... the certification process to promote standards of excellence for the field of eating ... for March 22 – 25, 2018 in Orlando, Florida at the Omni Resort ...
(Date:10/13/2017)... SAN LUIS OBISPO, Calif. (PRWEB) , ... October 13, 2017 , ... ... with Alzheimer’s or dementia. However, many long-term care insurance companies have a waiver for ... mean is the 90-day elimination period, when the family pays for care, is often ...
(Date:10/13/2017)... ... 2017 , ... Talented host, actor Rob Lowe, is introducing ... new episode of "Success Files," which is an award-winning educational program broadcasted on ... subject in-depth with passion and integrity. , Sciatica occurs when the sciatic nerve ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent ... sleep apnea using cutting-edge Oventus O2Vent technology. As many as 18 million ... by frequent cessation in breathing. Oral appliances can offer significant relief to about ...
Breaking Medicine News(10 mins):
(Date:9/27/2017)... NEW YORK , Sept. 27, 2017  DarioHealth Corp. (NASDAQ: DRIO), ... solutions, today announced that its MyDario product is expected to appear on ... for when The Dr. Oz Show airs in your area: http://www.doctoroz.com/page/where-watch-dr-oz-show ... The nine-time Emmy award-winning, The Dr. ... ...
(Date:9/22/2017)... , Sept. 22, 2017 AVACEN Medical ... device is now successfully helping those with the widespread ... Fibromyalgia diagnosed Amanda in Essex, England ... and washing my hair, experiencing no sleep at all, ... painful spasm… I cannot recommend [the AVACEN 100] enough, ...
(Date:9/13/2017)... 13, 2017   OrthoAtlanta has been named the ... Host Committee (AFHC) for the 2018 College Football Playoff (CFP) ... at Mercedes-Benz Stadium in Atlanta, Georgia . ... "I,m In" campaign, participating in many activities leading up to, ... ...
Breaking Medicine Technology: