FDA has provided the following information about a series of public meetings to take place on January 6-8, 2014. These meetings are open to the public and will be webcast.
A MESSAGE FROM FDA ABOUT THE WORKSHOPS PLANNED FOR JANUARY 6-8:
Dear friends in the rare disease community,
There are more than 7,000 rare diseases that affect roughly 30 million Americans, and, unfortunately, far too many of these patients do not yet have FDA-approved therapies to treat their conditions. Many children are impacted by rare diseases. It’s a monumental task to find safe and effective treatments for these diseases and no one group or organization can do it alone.
On January 6-8, 2014 at our White Oak campus in Silver Spring, Maryland, the FDA will bring together experts from many fields to discuss and share ideas for how to enhance the rare disease community’s efforts in developing new, safe, and effective therapies for rare diseases. We invite you to join us and learn more about many of the challenging issues related to the development of safe and effective medical products for adult and pediatric patients with rare diseases.
The first day will focus on drug and biological product development in general, while the second day will focus only on pediatrics. The third day will focus on medical device development for pediatric patients affected by rare diseases.
Separate registration is required for the workshops and registration closes December 20, 2013.
We will be seeking input from academic, clinical and treating communities, patients and advocacy groups, industry, and government agencies. This input will help inform the broad rare disease stakeholder community as to ways to encourage and accelerate much needed development of new therapies for rare diseases.
The format will mainly include discussion from the expert panels convened for each meeting session. Some sessions may also have time for limited public comment. However, any comments that are not able to be shared during the meeting may be sent to the docket for the meeting.
Here is a summary of the logistical information, along with links for more details.
Days 1 &2
Complex Issues in Developing Drug and Biological Products for Rare Diseases
WHEN: January 6-7, 2014
WHERE: FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002, as well as via webcast.
REGISTRATION and AGENDA: http://www.fda.gov/Drugs/
If you cannot attend day 1&2 or would like to submit written comments to the docket, go to: www.
Complex Issues in Developing Medical Devices for Pediatric Patients Affected by Rare Diseases
WHEN: January 8, 2014
WHERE: FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (section A of Rm. 1503), Silver Spring, MD 20993-0002, as well as via webcast.
REGISTRATION and AGENDA: http://www.fda.gov/
If you cannot attend day 3 or would like to submit written comments to the docket, go to: www.
The FDA is committed to working with all stakeholders in this effort. We encourage all who can attend to join us, either in person or via webcast, and we look forward to participating in this important event.
RareDisease Dialog is the official blog for the National Organization for Rare Disorders (NORD). NORD’s staff and friends will share information of interest to the entire rare disease community.
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