DIA/ FDA Orphan Drug Designation Workshop

Venue: Mumbai Cricket Association Recreation Center

Location: Mumbai, India

Event Date/Time: Jul 17, 2011 End Date/Time: Jul 19, 2011
Registration Date: Jul 10, 2011
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Participants (sponsors, clinical investigators, academics, biotechnology firms, etc.) will be called teams. Registration is limited to 12 teams at each workshop location (maximum of three individuals per team) and is accepted on a first-come, first-served basis.

Registration closes July 10, 2011.

Onsite registration will not be available for this workshop.

FDA announces two Orphan Drug Designation Workshops to present an opportunity for academics, biotechnology companies, pharmaceutical firms and other potential drug sponsors to learn about and prepare applications for requesting an orphan drug designation from the FDA in accordance with applicable regulatory criteria.

Participants (sponsors, clinical investigators, academics, biotechnology firms, etc.) will be called teams.

Each team will be expected to bring one candidate orphan drug that holds promise for the prevention, diagnosis or treatment of a rare disease or condition in the United States of America.

This will allow each team to directly engage in the practical matter of constructing an application for FDA orphan status designation.

To maximize the benefits of this workshop, teams are encouraged to come prepared with a working draft submission of a particular promising drug therapy.

• Application Writing
• One-on-One Guidance and Counseling with FDA
• Sponsors will have one 40-minute and one 20-minute consultative
session on the first full day and two 20-minute follow-up sessions on the second full day with an FDA Office of Orphan Products Development (OOPD) staff member.
• FDA’s expectation is that final applications will be submitted for orphan designation onsite at the close of the workshop.

FDA will not give any preferential review for applications received through the workshop.

Target Audience:
This program will benefit individuals in:
• Pharmaceutical firms
• Biotechnology companies
• Academia
• Clinical investigators
• Other potential drug sponsors

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