Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 21 October 2013 | By Alexander Gaffney, RAC,
The US Food and Drug Administration (FDA) is often seen as a reactive entity-reacting, that is, to the information contained within applications in order to render an approval decision, or to postmarketing adverse event data to determine if a product remains safe for use.
But as it illustrated in an announcement made on 21 October 2013, it can also be proactive when it needs to be.
FDA said it will be issuing 21 grants through its Orphan Products Grants Program with the intent of stimulating the development of treatments for rare diseases and conditions. In the US, the term "rare disease" is defined under the 1984 Orphan Drug Act (ODA), and refers to any disease for which there are fewer than 200,000 patients.
FDA said there are approximately 6,800 diseases currently known to science, cumulatively affecting nearly one in 10 Americans.
The grants are intended to turbo-charge early-stage research, some of which can struggle to find funding given the miniscule size of the eventual market or the presence of other low-cost competitors. Of the 21 grants listed by FDA as receiving funding, three are in phase 1 and 11 are in Phase II. None have yet reached Phase III, which are traditionally some of the most expensive to conduct. Typically government agencies will license research that successfully reaches Phase III studies to industry for further development.
FDA explained that it selected the diseases it did because they currently have "no available options" and represent "very vulnerable, difficult-to-treat populations."
The $14 million in funding ranges from a one-year, $167,000 contract to as much as $1.59 million spread out over four years. The agency's Orphan Products Grants Program has dispensed more than $300 million to more than 530 clinical studies and brought 50 products to market since its inception, FDA said.
The studies being funded this year are as follows:
FDA Funding Announcement
Tags: Neglected Diseases, Grant, Orphan Drug Act, Latest News, Orphan Drugs, Rare Diseases
Regulatory Focus newsletters
All the biggest regulatory news and happenings.