Navigation Links
NORD Calls FDA Action 'An Important Advance for Patients'

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



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:
(Date:6/27/2016)... ... June 27, 2016 , ... A revolution is underway. ... transport experience for the millions of people who require these medical transport services ... industry through the use of technology. Now, SmartEMS has put forth an industry-changing ...
(Date:6/26/2016)... , ... June 26, 2016 , ... PawPaws brand ... new product that was developed to enhance the health of felines. The formula is ... The two main herbs in the PawPaws Cat Kidney Support Supplement Soft ...
(Date:6/25/2016)... ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library on June 21 due ... up a new, often overlooked aspect of head lice: the parasite’s ability to live away ... a common occurrence, but a necessary one in the event that lice have simply gotten ...
(Date:6/25/2016)... ... ... On Friday, June 10, Van Mitchell, Secretary of the Maryland Department of Health and ... their exemplary accomplishments in worksite health promotion. , The Wellness at Work Awards took ... the BWI Marriott in Linthicum Heights. iHire was one of 42 businesses to receive ...
(Date:6/24/2016)... ... 24, 2016 , ... Marcy was in a crisis. Her son James, eight, was out of ... verbally and physically. , “When something upset him, he couldn’t control his emotions,” remembers Marcy. ... throw rocks at my other children and say he was going to kill them. ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , June 24, 2016   Pulmatrix, Inc ... company developing innovative inhaled drugs, announced today that it ... Russell Investments reconstituted its comprehensive set of U.S. ... "This is an important milestone for Pulmatrix," said ... increase shareholder awareness of our progress in developing drugs ...
(Date:6/23/2016)... , June 23, 2016 Any dentist who ... challenges of the current process. Many of them do not ... the technical difficulties and high laboratory costs involved. And those ... offer it at such a high cost that the majority ... Dr. Parsa Zadeh , founder of Dental ...
(Date:6/23/2016)... 2016 Capricor Therapeutics, Inc. ... biotechnology company focused on the discovery, development and ... enrollment in its ongoing randomized HOPE-Duchenne clinical trial ... of its 24-patient target. Capricor expects the trial ... of 2016, and to report top line data ...
Breaking Medicine Technology: