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Bookmark or Share- ORPHAN DRUG ACT - GovInfoORPHAN DRUG ACT 1. [As Amended Through P.L. 117–328, Enacted December 29, 2022] øCurrency: This publication is a compilation of the text of Public Law 97–414. It was last amended by the public law listed in the As Amended Through note above and below at the bottom of each page of the pdf version and reflects current law through the date of ...
- Designating an Orphan Product: Drugs and Biological ProductsThe FDA has authority to grant orphan drug designation to a drug or biological product to prevent, diagnose or treat a rare disease or condition. Orphan drug designation qualifies...
- Orphan Drug Act of 1983 - WikipediaThe 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, Tourette syndrome or muscular dystrophy which affect small numbers of individuals residing in the United States.
- The Story Behind the Orphan Drug Act | FDAThat law, the Orphan Drug Act, provided financial incentives to attract industry’s interest through a seven-year period of market exclusivity for a drug approved to treat an orphan disease,...
- What Is the Purpose of the Orphan Drug Act? | PLOS MedicineThe Orphan Drug Act (ODA) [ 1 ], first enacted in the United States in 1983, was set up to encourage the development of drugs for rare diseases. At that time, drug therapies for such diseases were rarely developed.
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