Public Workshop – Complex Issues in Developing Drug and Biological Products for Rare Diseases
The Food and Drug Administration (FDA) is announcing a public Workshop entitled “Complex Issues in Developing Drug and Biological Products for Rare Diseases.”
The purpose of the workshop is to discuss complex issues in clinical trials for developing drug and biological products (“drugs”) for rare diseases, including endpoint development and selection, use of surrogate endpoints and the accelerated approval pathway, clinical trial design, conduct and analysis, safety considerations, and dose selections; and to discuss ways to encourage and accelerate the development of new therapies for pediatric rare diseases. FDA is seeking input on these topics from academic, clinical, and treating communities; patients and advocacy groups; industry; and government agencies.
FDA is also holding a separate public workshop entitled “Complex Issues in Developing Medical Devices for Pediatric Patients Affected by Rare Diseases” that will be held on January 8, 2014. (Separate registration is required). The purpose of this workshop is to discuss issues related to medical devices for the diagnosis and treatment of pediatric patients affected by rare diseases. (Contact: Carol Krueger; 301-796-3241; firstname.lastname@example.org; see web page.
Date: January 6-7, 2014
Time: 8:00 a.m. to 5:00 p.m.
Location: FDA White Oak Campus
10903 New Hampshire Avenue,
Bldg. 31, Room 1503 (Great Room)
Silver Spring, Maryland 20993
FDA Campus Information
Public Meetings at the FDA White Oak Campus
Registration to Attend the Workshop:
If you wish to attend this Workshop, you must register by submitting a written request to CDERrarediseaseworkshop@fda.hhs.gov before close of business on December 20, 2013:
- Affiliation, Company or Organization
- E-mail address
- Telephone number
For those unable to attend in person, the public workshop will also be shown via webcast. Watch the webcast on January 6 - 7th from 8:00 a.m. to 5:00 p.m. Requirements and instructions for accessing the webcast are below. Please be sure to download the most up-to-date version of Flash Player.
You may access the webcast via this link: : https://collaboration.fda.gov/drugbiord/.
Adobe Connect Minimum Requirements
- View meetings on Windows, Macs, Unix, and Linux platforms
- Lan or Broadband internet connection
- Supports Internet Explorer, Firefox, Safari, Netscape Navigator, AOL
- Adobe Flash Player (no other downloads needed)
- VPN and Parachute compatible but not required
- Test my computer for Adobe Connect-Readiness
There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.
If you require special accommodations due to a disability, or need additional information regarding registration, please contact Tomeka Arnett, Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 51, Room 6338, Silver Spring, MD 20993, 301-796-2500, FAX: 301-847-3529, email@example.com.
For questions regarding workshop content please contact:
Tomeka Arnett, Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 51, Room 6338, Silver Spring, MD 20993, 301-796-2500, FAX: 301-847-3529, firstname.lastname@example.org.