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:5/5/2016)... -- Endo International plc (NASDAQ: ENDP ) ... , President, U.S. Branded Pharmaceuticals, has decided to ... of a successor. Mr. Lortie joined Endo in ... responsibility for all strategic, commercial and operational functions, ... commercial operations, managed markets, manufacturing, supply chain and ...
(Date:5/5/2016)... ORANGE COUNTY, Calif. , May 5, 2016 ... for nearly a decade due to concerns that ... advances in the approach to imaging, as well ... in a new era of medical peripherals that ... better care.   Ampronix  advanced medical imaging is a ...
(Date:5/5/2016)... , May 5, 2016 /PRNewswire/ ... announced the addition of the  "Europe ... - 2016"  report to their offering.  ... ) , ,The latest research ... Highlights - 2016, provides comprehensive insights ...
Breaking Medicine Technology:
(Date:5/6/2016)... ... May 06, 2016 , ... DrugDev President and CEO ... the pharmaceutical industry conducts clinical trials. This month Ibs was named No. 20 on ... and he was honored as a Tech Disruptor by the Philadelphia Business Journal. , ...
(Date:5/6/2016)... ... 06, 2016 , ... Featured cast and producers of the ... at the 2016 Learning Summit , June 12-15, in Paradise Valley, Arizona. ... stories—of complicated family issues, financial difficulties, and other personal obstacles—are the stories of ...
(Date:5/6/2016)... ... May 06, 2016 , ... A wide variety of national pet product manufacturers, companies and ... Safety Media Showcase Wednesday, May 18 from noon to 8 p.m. at New York City’s ... at new and established home, garden, outdoor and safety pet products in today’s marketplace. ...
(Date:5/6/2016)... ... May 06, 2016 , ... ... an upcoming episode, airing third quarter 2016, via Discovery Channel. Dates and show ... a leader in optimized drug discovery through innovative cellular analysis. In this segment, ...
(Date:5/6/2016)... ... May 06, 2016 , ... Logically, spring weather, with its moderate ... weather is too cold, dry or hot, water on the eye surface can evaporate, ... from the surrounding air. There’s only one problem, according to radio show and water ...
Breaking Medicine News(10 mins):