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:4/29/2016)... CA (PRWEB) , ... April 29, 2016 , ... Dr. ... cosmetic dental treatments to improve smiles. Cosmetic dentistry is a fast-growing field as more ... This offer allows patients to learn more about the options currently available to them ...
(Date:4/29/2016)... Grants Pass, OR (PRWEB) , ... April 29, 2016 , ... ... nutritionists suggest dinner as the meal to miss. That was among the many new ... True Nutrition, on a recent Sharon Kleyne Hour® Power of Water® radio show. Bonny ...
(Date:4/29/2016)... ... ... Regenerative Medicine Solutions (RMS) scored 94.8124 out of 100 on Tampa ... for Tampa’s Best Places to Work. They were ranked in the Big Category, which ... our team,” says RMS Human Resources Manager Irene Miller. “We work hard to build ...
(Date:4/29/2016)... ... , ... Nike Softball Camp at the College of Brockport in New York ... aged 10-18. All facets of the game will be covered; hitting, fielding, base-running, and ... of the finest softball facilities in the region. The outstanding professional college staff complement ...
(Date:4/29/2016)... ... April 29, 2016 , ... HEALTHCAREfirst ... and coding services, and Deyta Analytics, recently announced the recipients of the fourth ... of quality as measured from the caregiver’s point of view. The official list ...
Breaking Medicine News(10 mins):
(Date:4/27/2016)... PARIS , April 27, 2016 ... Year-Over-Year Including 42% Growth in Recurring Consumable Sales  ... Mauna Kea Technologies (Euronext: MKEA, OTCQX: MKEAY) ... today announced its sales for the first quarter ended ... business and the execution of its commercial strategy. ...
(Date:4/27/2016)... 2016 Transparency Market Research has ... - Global Industry Analysis, Size, Share, Growth, Trends, and ... global skincare devices market was valued at US$ 7,255.8 ... a CAGR of 10.1% from 2015 to 2023 to ... the full Skincare Devices Market (Treatment Device - LED Therapy ...
(Date:4/27/2016)... NEW DELHI , April 27, 2016 ... CSR initiative to save newborns ... ,s hospital for women & newborns in collaboration with Breast ... has launched the first Pasteurized Human Milk Bank, ,Amaara, in ... the best nutritional food source for infants and should be ...
Breaking Medicine Technology: