For Industry

FDA Marks Rare Disease Day 2013

The Orphan Drug Act (ODA) provided the first meaningful incentives to sponsors to develop needed medical products for the estimated 25 million Americans with rare diseases, defined under the ODA as diseases or conditions that affect fewer than 200,000 people in the United States. Since its passage over 400 products for rare diseases have received marketing approval.

Rare Disease Day 2013

FDA marks the 30th Anniversary of the passage of the ODA with recognition and events throughout 2013.

Join FDA and NIH in a two-day recognition of Rare Disease Day 2013 at the NIH campus, Natcher Auditorium, February 28 and March 1, 2013. Registration is free but encouraged.

February 28, 2013 marks the sixth international Rare Disease Day. The 2013 theme, “Rare Disorders Without Borders” is noted by the call to join and raise your hands to show solidarity with rare disease patients around the world.

For information about international Rare Disease Day activities visit:

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