The Orphan Drug Act
Orphan Drug Approval Laws - StatPearls - NCBI Bookshelf
In 1983, the United States Congress passed the Orphan Drug Law Act (ODA), which incentivized pharmaceutical companies to develop drugs aimed specifically at ...
Orphan Drug Act - Relevant Excerpts - FDA
The Congress finds that--- (1) there are many diseases and conditions, such as Huntington's disease, myoclonus, ALS (Lou Gehrig's disease), Tourette syndrome, ...
H.R.5238 - 97th Congress (1981-1982): Orphan Drug Act
Amends the Federal Food, Drug, and Cosmetic Act to allow sponsors of a drug for a rare disease or condition (orphan drug) to request the Secretary of Health ...
Orphan Drug Act of 1983 - Wikipedia
Orphan Drug Act of 1983 ... The Orphan Drug Act of 1983 is a law passed in the United States to facilitate development of orphan drugs—drugs for rare diseases ...
Designating an Orphan Product: Drugs and Biological Products | FDA
The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product to treat a rare disease or condition upon ...
The Orphan Drug Act Turns 40: NORD Celebrates Its Impact on ...
The Orphan Drug Act Turns 40: NORD Celebrates Its Impact on Rare Diseases ... Individuals suffering with rare diseases had very few therapeutic ...
What Is the Purpose of the Orphan Drug Act? - PMC
The 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.
A comprehensive study of the rare diseases and conditions targeted ...
The Orphan Drug Act (ODA) was signed into law in the United States on January 4th, 1983 [1]. Drug development for rare diseases can be ...
The Orphan Drug Act: Legal Overview and Policy Considerations
Congress enacted the Orphan Drug Act (ODA) (P.L. 97-. 414) in 1983 as a way to “facilitate the development of drugs for rare diseases or ...
Definition of orphan drug - NCI Dictionary of Cancer Terms
In 1983, the U.S. government passed a law, called the Orphan Drug Act, to give drug companies certain financial benefits for developing orphan drugs that ...
Policymaking for Orphan Drugs and Its Challenges | Journal of Ethics
The Orphan Drug Act of 1983 provides incentives to encourage the development of drugs for rare diseases, but available orphan drugs tend to be expensive and ...
The Orphan Drug Act Revisited | Law and Medicine - JAMA Network
The incentives established by the act are so appealing, and the requirements of traditional drug approval so onerous, that some pharmaceutical ...
Four Decades of Orphan Drugs and Priorities for the Future
The Orphan Drug Act (ODA) was enacted in the United States in 1983 in response to growing awareness of rare diseases, coupled with concerns ...
21 CFR Part 316 -- Orphan Drugs - eCFR
(a) A sponsor may request orphan-drug designation at any time in its drug development process prior to the time that sponsor submits a marketing application for ...
5 Things About the Orphan Drug Act
January 4 marks the anniversary of the Orphan Drug Act, which was enacted in 1983. Since the law was passed, it has successfully encouraged ...
Evaluating The Impact Of The Orphan Drug Act's Seven-Year Market ...
The Orphan Drug Act's market exclusivity incentive has played an increasingly smaller role in protecting rare disease drugs from competition.
It's Time to Reform the Orphan Drug Act - NEJM Catalyst
It is long past time to reform the Orphan Drug Act for the 21st century, and to evaluate current policies to assure that benefits are targeted at those orphan ...
High-expenditure Medicare drugs often qualified for Orphan Drug ...
The Orphan Drug Act (ODA) provides financial incentives—such as tax incentives and an exemption from marketing application fees—to encourage ...
Orphan Drug Regulations - Federal Register
360bb) to mandate orphan-drug designation of any drug for a rare disease or condition, even those that are the same drug as a previously ...
STAT. 2049 Public Law 97-414 97th Congress An Act - GovInfo
To amend the Federal Food, Drug, and Cosmetic Act to facilitate the development of drugs for rare diseases and conditions, and for other ...
The Orphan Drug Act
Orphan Drug Act of 1983
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, Tourette syndrome or muscular dystrophy which affect small numbers of individuals residing in the United States.
Orphan drug
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, due to the small population of patients affected by the conditions.