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Orphan drug - Wikipedia
An orphan drug is a pharmaceutical agent that is developed to treat certain rare medical conditions. An orphan drug would not be profitable to produce without government assistance, …
Designating an Orphan Product: Drugs and Biological Products
2024年8月12日 · The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor.
Orphan Drug Act of 1983 - Wikipedia
The Orphan Drug Act of 1983 is a law passed in the United States to facilitate development of orphan drugs—drugs for rare diseases such as Huntington's disease, myoclonus, ALS, …
What is an orphan drug? - Drugs.com
2024年9月27日 · Orphan drugs are medicines developed to help treat, prevent or diagnose rare “orphan” diseases, which are conditions that each affect fewer than 200,000 people in the U.S. …
Rare Diseases at FDA | FDA - U.S. Food and Drug Administration
2024年11月21日 · What is the Orphan Drug Act? The Orphan Drug Act is a law passed by Congress in 1983 that incentivizes the development of drugs to treat rare diseases. …
Orphan Drug Designation: Disease Considerations | FDA
For a complete list of orphan drug designations and approvals see the searchable Orphan Products Designation Database. FDA considers ovarian cancer, fallopian tube cancer, and …
What is an Orphan Drug? A Guide to Rare Disease Therapies
2025年1月23日 · Orphan drugs offer critical treatment options for rare diseases, improving quality of life for underserved patients and driving advancements in pharmaceuticals.
What is an orphan drug? - Johnson & Johnson
2024年2月28日 · An orphan drug is a drug intended for use in a rare disease. The World Health Organization defines a rare disease—sometimes referred to as an orphan disease—as one …
Orphan Drug Approval Laws - StatPearls - NCBI Bookshelf
2023年6月5日 · The Orphan Drug Approval Law of 1983 incentivized pharmaceutical companies to develop drugs for rare diseases by offering market exclusivity and tax credits. This activity …
Just under half of all Food and Drug Administration (FDA) drug approvals between 2017 and 2021 were for orphan drugs, which are drugs used to treat rare diseases or conditions.