The Rare Diseases and Orphan Products
Breakthrough Summit is the largest multi-stakeholder event dedicated to rare diseases and the only rare disease conference co-sponsored by the Food and Drug Administration (FDA).
The FDA's Office of Orphan Products
Development is dedicated to supporting the development of products that are promising for treatment and diagnoses of diseases that affect less than 200,000 Americans annually.
Seven-year marketing exclusivity to sponsors of approved orphan products
Timothy Cote, who was appointed Director of the Office of Orphan Products
Development in September, told "The Pink Sheet" that one of his top priorities in the coming year will be to persuade policymakers in Washington to increase the funding for grants for clinical development for orphan drugs.
To further encourage orphan drug availability, accompanying market-oriented incentives for orphan drug development were issued by the Office of Orphan Products
Development, under the auspices of FDA (11).
They oppose the initiatives by Senators Kennedy and Hatch to amend the law, because companies might be deprived of the fruits of their large investments in orphan product
R & D.
The FDA awards the grants through the Orphan Products
Grants Program to encourage clinical development of drugs, biologics, medical devices, or medical foods for use in rare diseases.
Food and Drug Administration's Office of Orphan Products
Development has granted orphan designation for AMIGAL in the United States, and the European Commission has designated AMIGAL as an orphan medicinal product in the European Union.
as the new director of the Office of Orphan Products
The ODA provided 7 years of market exclusivity and expanded tax credits for companies developing and marketing orphan drugs, established an Office of Orphan Product
Development at the Food and Drug Administration (FDA), and created the Orphan Products
are developed to treat rare diseases, or conditions that affect fewer than 200,000 people in the US.