Navigation Links
NORD Hosts Forum for FDA Commissioner and Patient Leaders
Date:1/21/2011

WASHINGTON, Jan. 21, 2011 /PRNewswire-USNewswire/ -- Food and Drug Commissioner Dr. Margaret Hamburg today conducted an unusual one-on-one dialogue with leaders of approximately 60 patient organizations at a forum hosted by the National Organization for Rare Disorders (NORD).

NORD organized the meeting so that Dr. Hamburg could share with the patient advocates her vision for FDA and hear directly from them their hopes, needs, and concerns.

"I come today to ask for your help, your guidance, and your support at this critical moment for FDA," Dr. Hamburg told the patient leaders. "We welcome and depend upon input from organizations like yours."

NORD President Peter L. Saltonstall assured the Commissioner that the patient community is eager to be involved and supportive of efforts to modernize and streamline the development of safe, effective treatments.

Dr. Hamburg said there are three areas she considers essential to position FDA for today's needs and those of the future:

  • to assure that FDA maintains "and earns every day" the trust and confidence of the American people
  • to modernize regulatory science to better incorporate scientific advances and
  • to address increasing globalization

"Many of the products we regulate today come from outside the country," she said.  "Of the active pharmaceutical ingredients in medical products Americans use, 80 percent come from outside the U.S."

Dr. Hamburg emphasized the importance of engaging internationally to share scientific data, harmonize the regulation process, and assure that critical needs of patients and families are being met.

Questions from the patient advocates covered a broad range of topics, including how FDA determines the risk/benefit ratio when considering new products and how it communicates its expectations to those developing new products.

Dr. Hamburg assured the patient representatives that their voices are heard at FDA.  She encouraged them to remain active participants in the regulatory process.

"Never underestimate the impact you bring to these issues," she said.


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

Related medicine technology :

1. Sao Paulo Hosts Strong Second Year for South American Pharma Events
2. Phonak Successfully Hosts Hearing Care for Adults 2009 Conference
3. PRA International Hosts an Infectious Diseases Audio Conference
4. Siemens Hosts First In a Series of Free Virtual Healthcare IT Conferences
5. PRA International Hosts a Late Phase Services Webinar Establishing Value for Diagnostics & Biomarkers in a Real-Life Setting
6. PRA International Hosts Audio Conference on Site and Patient Recruitment
7. PRA International Hosts Audio Conference on CV Drug Development
8. Webcast Alert: Isis Pharmaceuticals Hosts Expert Panel Conference Call to Discuss Mipomersen Data Presented at the ESC Congress 2010
9. OmniComm Systems, Inc. Hosts Autumn 2010 eClinical Forum Meeting
10. Luminex Corporation Hosts Eighth Annual Planet xMAP Europe in Vienna
11. Texas Childrens Hospital Hosts North American Investigators on Berlin Heart Trial
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/4/2017)... Centers for Disease Control and Prevention (CDC), influenza vaccination should take ... communities across Massachusetts , Connecticut , ... through the end of the month. *Some exclusions apply ... ... by the end of October, according to the Centers for Disease Control ...
(Date:10/2/2017)... Mich. , Oct. 2, 2017 Diplomat ... 8th Day Software and Consulting, LLC , and ... 8th Day Software, based in Tennessee ... LLC. 8th Day expands EnvoyHealth,s service offerings for health ... development. "In an ...
(Date:10/2/2017)... 2, 2017  AllianceRx Walgreens Prime, the combined central ... and pharmacy benefit manager Prime Therapeutics LLC (Prime), today ... included the unveiling of new signage at its headquarters ... as at a few other company-owned facilities across the ... patients, some of whom will begin to see the ...
Breaking Medicine Technology:
(Date:10/13/2017)... , ... October 13, 2017 , ... Yisrayl Hawkins, Pastor ... that explains one of the most popular and least understood books in the Holy ... and puzzling descriptions that have baffled scholars for centuries. Many have tossed it off ...
(Date:10/13/2017)... ... October 13, 2017 , ... “America On The Brink”: the Christian ... On The Brink” is the creation of published author, William Nowers. Captain Nowers ... a WWII veteran, he spent thirty years in the Navy. Following his career ...
(Date:10/12/2017)... ... October 12, 2017 , ... The company has developed a ... and regulatory authorities worldwide. From Children’s to Adults 50+, every formula has been ... standard. , These products are also: Gluten Free, Non-GMO, Vegan, Soy Free, ...
(Date:10/12/2017)... Maryland (PRWEB) , ... October 12, 2017 , ... ... magnetic drug delivery system that we intend to develop to enable prevention of ... can lead to severe hearing loss, especially in pediatric patients. For cisplatin, hearing ...
(Date:10/12/2017)... Chapel, FL (PRWEB) , ... October 12, 2017 , ... ... is holding a treadmill relay – Miles by Moonlight to raise money for the ... donating $300 or more. , Teams will work together to keep their treadmills ...
Breaking Medicine News(10 mins):