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/Fo
'/>"/>

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

Page: 1 2

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:4/16/2015)... , April 16, 2015  Hologic, Inc. (NASDAQ: ... cancer screening study i published on-line this ... journal of the American Cancer Society. ... the University of Pittsburgh Medical Center, supports current consensus guidelines ... that women 30-65 years of age be co-tested ...
(Date:4/16/2015)... April 16, 2015 Mallinckrodt plc (NYSE: ... today announced that it has completed its acquisition ... approximately $2.3 billion. The Ikaria acquisition extends Mallinckrodt,s ... reach into neonatal critical care with INOMAX ® ... for a highly vulnerable patient population. It also ...
(Date:4/16/2015)... , April 16, 2015  Rosewind Corporation (OTCMKTS: ... reverse merger with a newly formed specialty healthcare ... focus on addressing urological disorders. The merged company, ... Inc., has commenced operations and incorporates the pipeline ... The Company,s strategy is to build a late-stage ...
Breaking Medicine Technology:Hologic Comments on Important Cervical Cancer Screening Study Published in the American Cancer Society Journal, Cancer Cytopathology 2Hologic Comments on Important Cervical Cancer Screening Study Published in the American Cancer Society Journal, Cancer Cytopathology 3Hologic Comments on Important Cervical Cancer Screening Study Published in the American Cancer Society Journal, Cancer Cytopathology 4Mallinckrodt Completes Acquisition Of Ikaria 2Mallinckrodt Completes Acquisition Of Ikaria 3Mallinckrodt Completes Acquisition Of Ikaria 4Mallinckrodt Completes Acquisition Of Ikaria 5Rosewind Corporation Shifts Focus to Develop Late-Stage Therapeutics for Urological and Related Conditions 2Rosewind Corporation Shifts Focus to Develop Late-Stage Therapeutics for Urological and Related Conditions 3
... Fla., May 26, 2011 Tigris Pharmaceuticals, Inc., today ... Phase 2 clinical trial of AFP-464 (aminoflavone prodrug) with ... cancer patients. Molecular profiling will be used to pre-screen ... which has shown to predict sensitivity to ...
... 26, 2011 Medical Affairs serves as the linchpin for ... a successful market entry of a new product. ... trial strategy & planning, and publication strategy & planning, are ... the activities where organizations turn to Medical Affairs to play ...
Cached Medicine Technology:Tigris Pharmaceuticals Initiates Randomized Phase 2 Study of AFP-464 in ER-Positive Breast Cancer Patients 2Tigris Pharmaceuticals Initiates Randomized Phase 2 Study of AFP-464 in ER-Positive Breast Cancer Patients 3Medical Affairs Role in New Product Planning Detailed in Best Practices, LLC Report 2
(Date:4/17/2015)... 17, 2015 In Defense of Christians ... statement: “On Wednesday April 15th, the European Parliament joined ... resolution recognizing the Armenian Genocide, “paying tribute, on the ... one-and-a-half million innocent Armenian victims who perished in the ... the EU for this timely and needed recognition of ...
(Date:4/17/2015)... California (PRWEB) April 17, 2015 At ... Entertainment’s EcoLuxe Lounge and the “Salute to the Oscars” ... luxurious Beverly Hilton Hotel, overlooking the impressive Los Angeles ... were organized by Debbie Durkin, LA’s leading producer of ... Showcasing many of the world’s premier providers of eco-friendly ...
(Date:4/17/2015)... Scientists from the Icahn School ... U.S. and Venezuelan researchers, have discovered the most ... an isolated tribe of Yanomami Amerindians in the ... the Yanomami, previously unexposed to antibiotics or industrialized ... of people living in industrialized countries, and was ...
(Date:4/17/2015)... North Carolina (PRWEB) April 17, 2015 ... Family Dental Care has spent the last four ... dental care, performing procedures ranging from general cleanings to ... host a grand opening at their new office in ... the same services as their Concord office, including denture ...
(Date:4/17/2015)... (PRWEB) April 17, 2015 Ticket Down is a ... their 2015 Summer Tour. , The life of last-minute show announcements ... the popular group perform during the early part of 2015, but ... Will Wait,” “Little Lion Man,” “The Cave,” and “Believe,” will perform ... on June 2 at MCU Park at Coney Island in Brooklyn, ...
Breaking Medicine News(10 mins):Health News:In Defense of Christians Condemns Armenian Genocide 2Health News:In Defense of Christians Condemns Armenian Genocide 3Health News:Choices Recovery Speaks with Dakota Hood of “The Hunger Games” about Addiction in Hollywood 2Health News:Mount Sinai Scientists Find Unprecedented Microbial Diversity in Isolated Amazonian Tribe Previously Unexposed to Antibiotics or Processed Foods 2Health News:Mount Sinai Scientists Find Unprecedented Microbial Diversity in Isolated Amazonian Tribe Previously Unexposed to Antibiotics or Processed Foods 3Health News:Mumford and Sons Tickets in Clarkston/Detroit, Raleigh, Columbia/Baltimore, Chicago, Mansfield/Boston, Brooklyn, Calgary and Edmonton Now On Sale 2
... treatment has been found beneficial for boys affected by Duchenne muscular ... steroids helps them to walk on their own for a longer ... ,Duchenne muscular dystrophy occurs in one in 3,500 boys. Symptoms start ... ability to walk between ages nine and 11. There is no ...
... blessing for those women who are on estrogen therapy before the ... of reduction in the risk of Alzheimers disease or dementia. ... estrogen hormone therapy before the age of 65 cut their risk ... on hormone therapy before the age of 65. ...
... anymore for low test scores. According to American research, ... of their conception-which unfortunately they cant help. ... Paul Winchester of Indiana University School of Medicine claimed ... to perform worse than their peers in examinations. ...
... A widely used diabetes drug dramatically boosted the potency of ... cancer cell lines and to mice with tumors, scientists ... chemotherapy agent and the diabetes drug rosiglitazone halted or shrank ... either of the drugs given alone, according to the article ...
... a common condition among the senior lot in Australia. This is ... from an illness or accident. ,A study of ... almost 80 per cent were malnourished. At the same time, the ... were able to reduce their period of stay in the hospital. ...
... so that almost one in five babies rooms sport a television ... babies are sworn friends with the television by the age of ... to a survey by University of Texas researchers, 63 percent of ... switch it on or off at will. On an average babies ...
Cached Medicine News:Health News:Daily Steroids Helpful for Boys Down With Muscular Dystrophy 2Health News:Low Test Scores Of Children Linked To Their Date Of Conception 2Health News:Diabetes Drug Dramatically Boosts Potency of Platinum Chemotherapy 2Health News:Diabetes Drug Dramatically Boosts Potency of Platinum Chemotherapy 3
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
Medicine Products: