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:6/24/2016)... 24, 2016 Research and ... "Structural Electronics 2015-2025: Applications, Technologies, Forecasts" report ... In-Mold Electronics, Smart Skin, Structural Health Monitoring, ... Structural electronics involves electronic and/or electrical components ... replacing dumb structures such as vehicle bodies or ...
(Date:6/24/2016)... 2016 According to a new ... Pen Needles, Safety Pen Needles), Needle Length (4mm, 5mm, ... Mode of Purchase (Retail, Non-Retail) - Trends & Global ... the market for the forecast period of 2016 to ... Billion by 2021 from USD 1.65 Billion in 2016, ...
(Date:6/23/2016)... Research and Markets has announced the ... to 2022" report to their offering. ... patients with kidney failure, it replaces the function of kidneys ... blood and thus the treatment helps to keep the patient ... Increasing number of ESRD patients & substantial ...
Breaking Medicine Technology:
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... June 19, ... the dangers associated with chronic pain and the benefits of holistic treatments, Serenity ... who are suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) is a ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary Hypertension ... that it will receive two significant new grants to support its work to ... its 25th anniversary by recognizing patients, medical professionals and scientists for their work ...
(Date:6/24/2016)... ... June 24, 2016 , ... Dr. ... accelerated orthodontic treatment. Dr. Cheng has extensive experience with all areas of orthodontics, ... and accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary adjunct to orthodontic ...
(Date:6/24/2016)... ... , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, join The ‘Business ... to $12 an hour by 2020 and then adjusting it yearly to increase at the ... minimum wage, assure the wage floor does not erode again, and make future increases more ...
(Date:6/24/2016)... Norcross, Georgia (PRWEB) , ... June 24, 2016 ... ... Year” awards today at the Clinical Decision Making in Emergency Medicine conference in ... who have authored journal articles published in Emergency Medicine Practice and ...
Breaking Medicine News(10 mins):