Navigation Links
FDA: Orphan Drug Workshops Scheduled For Feb. 25-26 and Aug. 3-4, 2010
Date:12/23/2009

Agency Experts to Provide Guidance on Applying for Orphan Drug Designation

SILVER SPRING, Md., Dec. 23 /PRNewswire-USNewswire/ -- As part of its continuing effort to make the agency more transparent and accessible, the FDA has scheduled a series of workshops about orphan drug designation for academics, biotechnology companies, and those unfamiliar with the process. The FDA can grant a special status, known as orphan designation, for drug products intended to treat rare diseases.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

Orphan drugs are either drug or biologic products used to treat conditions affecting fewer than 200,000 people in the United States. Orphan drugs may be already-approved or experimental drugs.

The workshops will be held Feb. 25-26, 2010, in Claremont, Calif., and Aug. 3-4, 2010, in Minneapolis. At the workshops, 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. To help participants develop strong applications, FDA staff will provide one-on-one regulatory help.

To obtain orphan drug designation, drugs must be for the treatment, prevention or diagnosis of a rare disease or condition. Designation also requires there be a medical rationale for expecting the proposed drug to be effective in the treatment, prevention, or diagnosis of that disease or condition.

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. After designation, the drug must then be submitted for review through the FDA marketing approval process, which evaluates the drug for safety and efficacy.

During the past 25 years, the FDA has granted orphan drug designation to about 2,100 drugs, of which 344 have become approved products.

For more information:

Do a Designation: FDA Orphan Drug Workshops

http://www.fda.gov/downloads/ForIndustry/DevelopingProductsforRareDiseasesConditions/UCM189586.pdf

Designating an Orphan Product: Drugs and Biologics

http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/HowtoapplyforOrphanProductDesignation/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


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Pharmion and MethylGene Announce U.S. Orphan Drug Designation Granted for MGCD0103 for the Treatment of Hodgkins Lymphoma
2. Advanced Life Sciences Announces ALS-357 Granted FDA Orphan Drug Designation for Metastatic Melanoma
3. US FDA Grants Orphan Drug Status to Immtechs Pafuramidine for Treatment of African Sleeping Sickness
4. Knopp Neurosciences Receives Orphan Designation for KNS-760704 for Treatment of ALS
5. Voices to Unite in Los Angeles for 6,000 Children Orphaned Daily
6. Celldex Therapeutics Announces Orphan Drug Designation for CDX-110, a Novel EGFRvIII Vaccine for Glioblastoma Multiforme
7. Insmed Receives FDA Orphan Drug Designation for IPLEX(TM) in the Treatment of Myotonic Muscular Dystrophy
8. Antheras A-001 Receives Orphan Drug Status for the Prevention of Acute Chest Syndrome in Patients With Sickle Cell Disease
9. Jazz Pharmaceuticals, Inc. Announces Receipt of FDA Orphan Drug Designation for Recurrent Acute Repetitive Seizures Product Candidate
10. Fovea Pharmaceuticals Receives Orphan Drug Designation from EC for RdCVF for the Treatment of Retinitis Pigmentosa
11. ActivBiotics Receives Orphan Drug Designation from the European Medicines Agency for Superoxide Dismutase Mimetic, M40403, in Oral Mucositis Indication
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/22/2017)...  Soligenix, Inc. (Nasdaq: SNGX ) ... focused on developing and commercializing products to treat ... need, announced today that its proprietary formulation of ... for the treatment of psoriasis. The issued patent, ... skin conditions, complements the method of treatment claims ...
(Date:2/21/2017)... 21, 2017 Micro Guide Catheters Market: ... http://www.reportlinker.com/p04711314-summary/view-report.html Micro Guide Catheters are ... specialty clinics and ambulatory surgery centers etc. Micro ... The selection of micro guide catheter depends on ... human body. Micro guide catheters are available in ...
(Date:2/21/2017)... Auburn University College of Veterinary Medicine has become the 2 ... (HVM) Chamber.  The University of Florida has been working with ... and now Auburn University will enable its students to learn ... exclusively for the treatment of animals. HVM is ... universities like Auburn and ...
Breaking Medicine Technology:
(Date:2/21/2017)... (PRWEB) , ... February 21, ... ... of technology-enabled clinical trial solutions, today announced the further expansion of its ... applications they can leverage as part of Bioclinica’s extensive and growing eHealth ...
(Date:2/21/2017)... ... February 21, 2017 , ... HIMSS is ... connected care demonstration spanned multiple health information systems including OpenEMR, EMRDirect, and ... providers have no Health Information Exchange outside of faxing. Medal’s innovative technology “meets ...
(Date:2/21/2017)... ... February 21, 2017 , ... CLICKco LLC, a ... its products are now available for purchase on RonnieColemanNutrition.com, a popular website for ... popular among health-conscious consumers who love coffee but are looking to add more ...
(Date:2/20/2017)... ... 20, 2017 , ... MRI screening improves early diagnosis of breast cancer in ... online in the journal Radiology . , MRI has long been known ... ultrasound. Currently, guidelines reserve breast MRI screening for women who have a strong family ...
(Date:2/20/2017)... ALEXANDRIA, VA (PRWEB) , ... February 20, 2017 , ... ... with Cambridge Healthcare to open and operate a state-of-the-art memory care community in Alexandria, ... of 2018 on a site just outside of Old Town. , The three-story ...
Breaking Medicine News(10 mins):