CDER Rare Diseases Public Workshop

Strategies, Tools, and Best Practices for Effective Advocacy in

Rare Diseases Drug Development

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) is sponsoring a public workshop on rare disease advocacy Monday, October 30, 2017. This public workshop builds upon previous CDER patient advocacy public workshops and is primarily for the rare disease community members to help them effectively understand FDA's needs for enhancing drug development. This workshop will include case studies demonstrating the beneficial overlap of effective advocacy techniques and FDA regulations in rare disease drug development.

The workshop agenda is now available:

REGISTRATION

There is no registration fee to attend the public workshop. Early registration is recommended because seating is limited. Registration will be on a first-come, first-served basis. There will be no onsite registration. Persons interested in attending this workshop must register before October 20, 2017. Those without internet access should contact Francis Kalush to register. If you have signed up for to attend the workshop via webcast, please click the following link on October 30: https://collaboration.fda.gov/cderrarediseases103017/.

LOGISTICAL INFORMATION

Public workshop participants (non-FDA employees) should enter through Building 1 of the White Oak Campus where routine security check procedures will be performed. If special accommodations are necessary due to a disability, please contact Francis Kalush at least 7 days in advance. Click here for additional meeting information on parking, security, and similar topics.

CONTACT INFORMATION

Francis Kalush, Ph.D., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, PASE-RARE-DISEASES@fda.hhs.gov.

TRANSCRIPTS

A transcript of the workshop will be available for review at the FDA Freedom of Information Act and Dockets Public Reading Room in room 1061 of 5630 Fishers Lane, Rockville, MD 20852, and on the Internet at http://www.regulations.gov. Transcripts will also be available in either hard copy or on CD-ROM after submission of a Freedom of Information request.

Center for Drug Evaluation and Research Rare Diseases Public Workshop: Strategies, Tools, and Best Practices for Effective Advocacy in Rare Diseases Drug Development

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