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:10/4/2017)... 2017 OBP Medical , a ... devices, today announced regulatory approval from ... Agência Nacional de Vigilância Sanitária (ANVISA)) to market ... retractor with integrated LED light source and smoke ... exposure of a tissue pocket or cavity during ...
(Date:10/2/2017)... , Oct. 2, 2017  Eli Lilly and Company ... results for the third quarter of 2017 on Tuesday, ... call on that day with the investment community and ... The conference call will begin at 9 a.m. ... access a live webcast of the conference call through ...
(Date:10/2/2017)... 2, 2017 Halo Labs announces the European launch of ... the HORIZON at MIBio 2017 in Cambridge, U.K ... particulate matter in biopharmaceutical samples with unprecedented speed and sensitivity while ... technique Backgrounded Membrane Imaging. ... HORIZON subvisible particle analysis system ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... ... The American Board of Family Medicine's (ABFM) Board of Directors has selected ... Dr. James C. Puffer upon his retirement. Dr. Newton will serve in the position ... the end of 2018. Upon assuming the role of President and CEO on January ...
(Date:10/13/2017)... ... October 13, 2017 , ... Lori R. Somekh, founder ... of ElderCounsel, a national organization of elder law and special needs planning attorneys. “Membership ... rules. It also provides a forum to network with elder law attorneys nationwide,” said ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network ... advocate for action towards gender equality at their inaugural Summit in New York City ... and reached a social audience of over 3 million. To watch the Mobilize Women ...
(Date:10/13/2017)... ... October 13, 2017 , ... Coveros, a leader ... been awarded a contract by the Center for Medicare and Medicaid Services (CMS). ... the enterprise use of Agile methodologies in a consistent and high value manner ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent and San ... using cutting-edge Oventus O2Vent technology. As many as 18 million Americans are ... cessation in breathing. Oral appliances can offer significant relief to about 75 percent ...
Breaking Medicine News(10 mins):