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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. The conditions that orphan drugs are used to treat are referred to as orphan diseases. The ...
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.
The organization grew out of an "informal coalition" of support groups and families called together in the late 1970s to advocate legislation supporting development of orphan drugs, or drugs for treating rare diseases. [5] They succeeded in getting the United States Congress to pass the Orphan Drug Act (ODA) in early 1983. [2] [5] [6]
Orphan drugs -- medications meant for small patient populations with rare, dangerous diseases -- can be a rewarding business for biotech firms that strike gold. Drugs can cost hundreds of ...
Since being signed into law 30 years ago, the Orphan Drug Act, or ODA, has resulted in the approval of more than 400 new drugs and biologic products in the United States. The goal of the ODA is to ...
According to Thomson Reuters in their 2012 publication "The Economic Power of Orphan Drugs", there has been increased investing in orphan drug research and development partly since the U.S. Congress enacted the Orphan Drug Act, giving an extra monopoly for drugs for "orphan diseases" that affected fewer than 200,000 people in the country. [13]
Orphan drug status, which is given to drugs meant for the treatment of rare diseases, offers drug developers a path to faster approval and enhanced market exclusivity. So let's look at a small ...
Prior to the RDA was the Orphan Drug Act of 1983, which was designed to facilitate the development and commercialization of drugs to treat rare diseases, termed orphan drugs. This act, however, did not provide for the creation of a centralized structure able to coordinate research or recommend agendas that would better facilitate research and ...