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:3/24/2017)... India , March 24, 2017 A ... market has been growing rapidly as the global sales of Adcetris ... the growth in the antibody drug conjugates market is driven by ... of cancer and wider therapeutic window offered by ADCs. ... Browse 3 Tables and 94 ...
(Date:3/24/2017)... Research and Markets has announced the addition ... report to their offering. ... The report provides separate comprehensive analytics for the US, ... , Asia-Pacific , Latin America , ... period 2015 through 2022. Also, a six-year historic analysis is provided for ...
(Date:3/24/2017)... , March 23, 2017  HealthMine surveys with ... 2017 revealed that health plan members want help from ... to stay engaged in their health, 2) help closing ... integrated platform for health and 5) relevant, real-time guidance. ... and lowering healthcare costs. A ...
Breaking Medicine Technology:
(Date:3/25/2017)... ... ... Swissray is pleased to announce the release of the ELITE DXA, a new bone ... scan window, which is more than double that of existing bone densitometers. Historically, subjects ... an accurate total body bone density or body composition study. The ELITE DXA ...
(Date:3/24/2017)... ... 2017 , ... Digital Scientists, a software innovation lab specializing in web design ... Greenville, South Carolina location. The lab has set up shop at the renowned ... with South Carolina clients for years from our office here in Atlanta,” explains Digital ...
(Date:3/24/2017)... ... March 24, 2017 , ... Mlynarek Insurance Agencies, a ... and business owners across eastern Michigan, is connecting with the Oxford/Orion FISH Food ... difficulties. , The Oxford/Orion FISH Food Pantry works to ensure homeless, hungry, and ...
(Date:3/24/2017)... (PRWEB) , ... March 24, 2017 , ... ... two panels at the Advanced ERISA Benefit Claims Litigation seminar in Chicago, Illinois. ... the Administrative Record, The majority of cases litigated under ERISA involve claims for ...
(Date:3/24/2017)... ... March 24, 2017 , ... Judy Buchanan, co-owner of ... Frederick, MD. Judy says, “I am passionate about sharing Reiki as a holistic, ... difficult and challenging time.” , A Certified Medical Reiki™ Master trained by Raven ...
Breaking Medicine News(10 mins):