Navigation Links
Fourth FDA Orphan Drug Designation Workshop Scheduled for Feb. 28 - March 1, 2011
Date:1/27/2011

SILVER SPRING, Md., Jan. 27, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration has scheduled its fourth orphan drug designation workshop for academics, biotechnology companies, and those unfamiliar with the process for Feb. 28 – March 1, 2011, in Claremont, Calif. in collaboration with Keck Graduate Institute.

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

The workshop, co-sponsored by the National Organization of Rare Disorders and the Genetic Alliance, will focus on the process used by the FDA to grant a special status, known as orphan drug designation, for drug products intended to treat rare diseases. Three similar workshops were held in 2010.

Orphan drugs are either drugs or biologics intended for the treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the United States, or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing the drug. 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.

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. Designation 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.

For more information:

  • FDA: Orphan Drug Workshop

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

  • Developing Products for Rare Diseases and Conditions

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

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. Zimmer Reports Fourth Quarter and 2010 Financial Results
2. Solos Endoscopy, Inc. Reports $90,005 in Sales Revenue for Fourth Quarter 2010
3. Lilly Reports Fourth-Quarter and Full-Year 2010 Results, Provides 2011 Financial Guidance
4. Video From AstraZeneca Available on thenewsmarket.com: AstraZeneca Announces Fourth Quarter and Full Year Results 2010
5. Covance Reports Fourth Quarter Revenue of $492 Million, GAAP EPS of $0.45, and Pro Forma EPS of $0.56
6. Solta Medical Announces Full Year and Fourth Quarter 2010 Results Release and Conference Call
7. NxStage® to Report Fourth Quarter and Full Year 2010 Financial Results
8. Johnson & Johnson Reports 2010 Fourth-Quarter and Full-Year Results
9. Amgen’s Fourth Quarter 2010 Adjusted Earnings Per Share Increased 11 Percent to $1.17; Full Year 2010 Adjusted Earnings Per Share Increased 6 Percent to $5.21
10. Medco Announces Date for Release of Fourth-Quarter and Full-Year 2010 Financial Results
11. BioMarin to Host Fourth Quarter and Full Year 2010 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2016)... 2016 Niederländische Chirurgen haben ... es Ärzten erlaubt, ihre Expertise weltweit zu teilen ... Live Streaming mit einer Instant-Messaging-Funktion und der Möglichkeit, ... in Europa, Afrika, Asien und den ... Plattform registriert. Information und Weiterbildung   ...
(Date:5/24/2016)... , May 24, 2016 ... beide primären Endpunkte und ... Überlegenheit in ‚ausgezeichneter plus guter ... Colons    ,      (Logo: ... gab heute neue positive Daten von der MORA-Studie ...
(Date:5/24/2016)... 24, 2016  Diana Russell suffers from a form ... the inside out.  This disease has put her in ... children and grandchildren to leave her home.  Because of ... cannot haul the wheelchair.  So if there is a ... Diana is left to wait for the bus. ...
Breaking Medicine Technology:
(Date:5/25/2016)... ... May 25, 2016 , ... New studies published ... injured workers across 15 states. The outcomes examined in these studies include recovery ... care, and satisfaction with medical care. , “The goal of the studies is ...
(Date:5/25/2016)... , ... May 25, 2016 , ... CloudLIMS, joins an ... and Life Sciences Tech Solution Providers list of 2016 by CIOReview. , In a ... and Life Sciences Tech Solution Providers 2016 has been concluded with. The positioning is ...
(Date:5/25/2016)... ... May 25, 2016 , ... The World Molecular Imaging ... Molecular Imaging.” The focus of ADDMI-IG will be geared towards how using molecular ... issues. Through ADDMI-IG WMIS will provide a platform for productive discussions about the ...
(Date:5/25/2016)... ... 2016 , ... DKT International, one of the largest private ... to release their 2015 global impact data. In 2015, DKT served over 30 ... and 3.8 million unsafe abortions across 21 countries worldwide. , “We are ...
(Date:5/25/2016)... ... May 25, 2016 , ... Afrimesure specializes in ... and pharmaceutical, to food and HVAC facilities. Their knowledgeable staff also takes care ... For medical applications, Afrimesure offers a variety of MadgeTech systems available for sterilization ...
Breaking Medicine News(10 mins):