Navigation Links
FDA Schedules Third Orphan Drug Workshop for Nov. 4-5, 2010
Date:10/13/2010

SILVER SPRING, Md., Oct. 13 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration has scheduled the third in a series of workshops on orphan drug designation for academics, biotechnology companies, and those unfamiliar with the process for Nov. 4-5, 2010, in Lansdowne, Va.

(Logo:  http://photos.prnewswire.com/prnh/20090824/FDALOGO)

(Logo:  http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

The workshop, in collaboration with the Drug Information Association, will focus on the process used by the FDA to grant a special status, known as orphan designation, for drug products intended to treat rare diseases. Similar workshops were held earlier this year in Claremont, Calif., and Minneapolis.

Orphan drugs are either drug or biologic products used to treat diseases or conditions affecting fewer than 200,000 people in the United States. Orphan drug designation is available for drugs already approved for another disease or condition or for experimental drugs that have not been previously approved.

During the workshop, participants will propose a specific drug for a specific rare disease and work on an orphan designation application to submit to the FDA at the conclusion of the workshop. FDA staff will provide one-on-one guidance to help participants develop strong applications.

To obtain orphan drug designation, drugs must be for the treatment, prevention or diagnosis of a rare disease or condition. Designation also requires there be a scientific rationale for expecting the proposed drug to be effective in the treatment, prevention, or diagnosis of that disease or condition.

Orphan designation qualifies the applicant to receive certain benefits, such as tax credits and marketing incentives, from the federal government in exchange for developing the drug. After designation, the orphan drug may then be submitted for review through the FDA marketing approval process, which evaluates the drug for safety and efficacy.

Since 1983, when the Orphan Drug Act was passed, the FDA has received 3,212 applications for orphan drug designation and has granted orphan drug designation to about 2,250 drugs, of which 361 have become approved products.

For more information:

  • DIA/FDA: Orphan Drug Designation Workshop Brochure

http://www.fda.gov/downloads/ForIndustry/DevelopingProductsforRareDiseasesConditions/UCM215487.pdf

  • Developing Products for Rare Diseases and Conditions

http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm

  • Drug Information Association

http://www.diahome.org/DIAHome/Home.aspx

Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Varian Medical Systems Schedules Fourth Quarter FY2010 News Release and Conference Call
2. Misonix Schedules Fourth Quarter and Fiscal 2010 Financial Results Conference Call; September 28, 2010 at 4:30 p.m. Eastern
3. Renhuang Schedules Conference Call to Discuss FY 2010 Third Quarter Results
4. Varian Medical Systems Schedules Investor Meeting and Fiscal Year End Review at ASTRO in San Diego, November 2, 2010
5. Sunridge Schedules European Meetings
6. Unilife Corporation Schedules Fiscal 2010 Fourth Quarter and Year End Conference Call for Monday, August 30, 2010
7. WuXi PharmaTech RESCHEDULES Second-Quarter 2010 Earnings Conference Call
8. Orexigen® Therapeutics Schedules August 5, 2010 Webcast Discussion of Financial Results for the Second Quarter Ended June 30, 2010
9. VirtualScopics Schedules Second Quarter 2010 Earnings Announcement
10. Thoratec Schedules Second Quarter Conference Call, Webcast
11. Alere Inc. Schedules Conference Call for 10:00 a.m. ET July 28, 2010 to Discuss Second Quarter 2010 Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/18/2017)... , Pa. and KALAMAZOO, Mich. , Sept. ... Penn. , and OptiMed Specialty Pharmacy of ... partnership to offer a strategic hub service that expedites ... highly sought-after personal spirometer, Spiro PD 2.0, and wellness ... A spirometer is a medical device used to measure ...
(Date:9/13/2017)... --  OrthoAtlanta has been named the official orthopedic and ... for the 2018 College Football Playoff (CFP) National Championship to ... in Atlanta, Georgia . OrthoAtlanta is proud ... participating in many activities leading up to, and including the ... ...
(Date:9/12/2017)... LAKES, N.J. , Sept. 12, 2017  Consumer reviews on ... Embrace Hearing as the number one company for hearing aids, ... ReSound™ and fifteen other brands. ... Embrace Hearing Named #1 by Consumers For Hearing Aids ... Embrace Hearing is an online store that provides ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... 13, 2017 , ... Talented host, actor Rob Lowe, is ... a new episode of "Success Files," which is an award-winning educational program broadcasted ... each subject in-depth with passion and integrity. , Sciatica occurs when the sciatic ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the Mountains to the ... save lost souls in the Philippines. “The Journey: From the Mountains to the Mission ... of the Bible. She has taught all ages and currently teaches a class of ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... services for healthcare compliance program management, will showcase a range of technology and ... for Assisted Living (NCAL) Convention and Expo to be held October 14–18, 2017 ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest ... its plans to open a flagship location in Covington, LA at 401 N. U.S. ... Go store next to Office Depot in the Holiday Square shopping center. Its location ...
(Date:10/12/2017)... ... ... IsoComforter, Inc. ( https://isocomforter.com ), one of the Nation’s premier ... of the shoulder pad. The shoulder pad provides optimal support and full contact ... using cold therapy. By utilizing ice and water that is circulated from an insulated ...
Breaking Medicine News(10 mins):