Navigation Links
FDA Launches Orphan Drug Workshop at KGI

CLAREMONT, Calif., Dec. 9 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has announced the launch of an orphan drug workshop series--an opportunity for biotechnology companies, pharmaceutical firms, academics and other interested parties to spend two days creating applications for orphan status designation, under the guidance of staff from FDA's Office of Orphan Products Development (OOPD). The first workshop is planned for Feb. 25-26, 2010, hosted by the Center for Rare Disease Therapies at Keck Graduate Institute (KGI) in Claremont, Calif.

The intent of this workshop is to simplify and demystify entry into orphan drug development. Each attendee must come prepared to work on an application for a particular drug or therapy.

There will be an introductory presentation, but most of the time over the two-day period will be spent writing an application for orphan designation for specific products, which will be submitted at the close of the workshop.

Having a product designated an "orphan" provides important incentives and can be done at any time prior to submission of a marketing application. To receive orphan designation, the submitting organization must convince the FDA-OOPD that the proposed drug is targeted toward a rare disease (one with a patient population of fewer than 200,000 people) and holds promise for treating the rare disease.

For information about the workshops, contact Lucienne Nelson at or 301-827-3666.

The National Organization for Rare Disorders is partnering with FDA on these workshops, the second of which will be held at the University of Minnesota on Aug. 3-4, 2010.


Educating the future leaders of the bioscience industry, Keck Graduate Institute (KGI) offers an interdisciplinary graduate education through its Master of Bioscience (MBS), Postdoctoral Professional Masters in Bioscience Management (PPMBS), PhD programs, and other degrees. Using team-based learning and real-world projects, KGI's innovative curriculum seamlessly combines applied life sciences, bioengineering, bioethics and business management. KGI also has a robust research program concentrating on the translation of basic discoveries in the life sciences into applications that can benefit society. KGI is a member of The Claremont Colleges, located in Claremont, California.

Keck Graduate Institute of Applied Life Sciences is dedicated to education and research aimed at translating into practice, for the benefit of society, the power and potential of the life sciences.

SOURCE Keck Graduate Institute

SOURCE Keck Graduate Institute
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Iomai Launches Phase 1/2 Safety Study of Dose-Sparing Patch for Use With Pandemic Influenza Vaccine
2. Keeping the Data Center Clean: ATEN Launches Industry-First KVM Switches with Antimicrobial Nanocoating to Protect Products from Bacteria Surviving on Surfaces
3. Cell Therapeutics, Inc. (CTI) Launches Phase III Study for Pixantrone in Relapsed Indolent Non-Hodgkins Lymphoma (NHL)
4. Tengion Launches Second Phase 2 Clinical Trial of Regenerated Human Organ
5. Strategic Diagnostics Launches Initial Oncology-Targeted Antibody Reagent Catalog
6. deCODE Launches Phase II Clinical Testing of DG051 for the Prevention of Heart Attack
7. Premier Micronutrient Launches Supplement for Hearing Health
8. deCODE Launches deCODE MI(TM) -- A Test for a Major Genetic Risk Factor for Early-onset Heart Attack
9. PDHI Launches ConXus Rewards, Announces Partnership With Hallmark Insights to Support Incentive-Driven Wellness Programs
10. Seal Shield Launches Worlds First Antibacterial, Dishwasher Safe Keyboard and Mouse for Infection Control
11. Launches STD Social Networking Site Balancing Dating with Online Support Features
Post Your Comments:
(Date:11/26/2015)... , November 26, 2015 /PRNewswire/ ... --> adds "Global ... and "Investigation Report on China Repaglinide ... 2021 forecasts data and information to ... . --> ...
(Date:11/26/2015)... 26, 2015 ... "Radioimmunoassay Market by Type (Reagents & ... Academics, Clinical Diagnostic Labs), Application (Research, Clinical ... 2020" report to their offering. ... addition of the "Radioimmunoassay Market by ...
(Date:11/25/2015)...  The total global healthcare industry is expected to grow ... Latin America has the highest projected growth at ... Japan ), is second with growth projected at 11.5%. ... healthcare expenditure. In 2013-2014, total government funded healthcare was nearly ... to 41.2% in 2013-2014. In real terms, out of pocket ...
Breaking Medicine Technology:
(Date:11/27/2015)... CO (PRWEB) , ... November 27, 2015 , ... According ... cities are not changing the way that they are handling security in light of ... police and security presence in an attempt to stop an attack from reaching U.S. ...
(Date:11/27/2015)... County, CA (PRWEB) , ... November 27, 2015 , ... ... season , The company is offering customers 10% off of their purchase of lice ... any treatment at full price. According to a company spokesperson. “Finding lice is a ...
(Date:11/27/2015)... ... November 27, 2015 , ... Intellitec ... Dynamics SL User Group (MSDSLUG). Recognized as Microsoft’s official group for end users ... Dynamics SL software users, partners, industry experts and representatives. Intellitec Solutions’ membership status ...
(Date:11/27/2015)... IL (PRWEB) , ... November 27, 2015 , ... ... of the largest, most successful and prominent nonprofit healthcare organizations in the country. ... governance involvement with various organizations, and helped advance the healthcare industry as a ...
(Date:11/26/2015)... ... ... Inevitably when people think Thanksgiving, they also think Holiday sales and start ... and Cyber Monday massage chair sales to receive the best pricing on ... find the best massage chair deals, they can see all of the coupons in ...
Breaking Medicine News(10 mins):