Navigation Links
Fourth FDA Orphan Drug Designation Workshop Scheduled for Feb. 28 - March 1, 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.


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

  • Developing Products for Rare Diseases and Conditions

Media Inquiries: Sandy Walsh, 301-796-4669,

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 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:
(Date:11/25/2015)... Nov. 25, 2015 On Tuesday, November ... bellwether trial against Wright Medical Technology, Inc. for ... Conserve metal-on-metal hip implant device, awarded $11 million ... two week trial and three days of deliberations, ... device was defectively designed and unreasonably dangerous, and ...
(Date:11/25/2015)... Nov. 25, 2015  Henry Schein, Inc., the world,s ... office-based dental, medical and animal health practitioners, will unveil ... Henry Schein ConnectDental® Pavilion , which brings together ... open solutions designed to help any practice or laboratory ... for a schedule of experts appearing at the ...
(Date:11/25/2015)... plc (NYSE: AGN ) today announced that it has ... Attorney General,s Office to end the litigation under ... the Attorney General over the decision of Forest Laboratories, Inc., ... now generic version of memantine immediate release tablets.  Under the ... counterclaims against New York , and has ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... November 27, 2015 , ... According to an ... changing the way that they are handling security in light of the recent terrorist ... presence in an attempt to stop an attack from reaching U.S. soil. Especially around ...
(Date:11/27/2015)... (PRWEB) , ... November 27, 2015 , ... Lizzie’s Lice ... The company is offering customers 10% off of their purchase of lice treatment product. ... at full price. According to a company spokesperson. “Finding lice is a sure way ...
(Date:11/27/2015)... DE (PRWEB) , ... November 27, 2015 , ... ... member of the well-respected Microsoft Dynamics SL User Group (MSDSLUG). Recognized as Microsoft’s ... an independent group of Microsoft Dynamics SL software users, partners, industry experts and ...
(Date:11/27/2015)... ... November 27, 2015 , ... ... most successful and prominent nonprofit healthcare organizations in the country. They have overseen ... various organizations, and helped advance the healthcare industry as a whole through their ...
(Date:11/26/2015)... Vegas, NV (PRWEB) , ... November 26, 2015 , ... ... shopping strategy. Many customers choose to buy during the Black Friday and Cyber ... gifts. Shoppers don’t need to search the Internet high and low to find the ...
Breaking Medicine News(10 mins):