orphan products


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Related to orphan products: Orphan Drug Act

or·phan pro·ducts

drugs, biologicals, and medical devices (including diagnostic in vitro tests) that may be useful in either common or rare diseases but that are not considered commercially viable.
Synonym(s): orphan drugs

or·phan prod·ucts

(ōr'făn prod'ŭkts)
Drugs, biologicals, and medical devices (including diagnostic in vitro tests) that may be useful in treating rare diseases but are not considered commercially viable.

or·phan prod·ucts

(ōr'făn prod'ŭkts)
Drugs, biologicals, and medical devices that may be useful in either common or rare diseases but not considered commercially viable.
References in periodicals archive ?
The European Office of Orphan Products Development will therefore support the establishment of groups of persons with the same rare conditions to play a role in increasing awareness of the disease within the population and will coordinate their activities at national and community levels.
Since its creation in 1983, the Orphan Products Grants Program has provided more than $350 million to fund more than 570 new clinical studies and supported the marketing approval of more than 50 products.
Dedicated to cancer and supportive care treatment with a focus on resistance targeting and orphan products, BioAlliance (Paris:BIO) conceives and develops innovative products, for specialty markets especially in the hospital setting and for orphan or rare diseases.
Escend Pharmaceuticals Inc, a privately held company focused on the development of small molecule therapeutics for oncology orphan diseases, has received orphan drug designation for its lead product candidate, ES-3000, from the FDA Office of Orphan Products Development, it was reported yesterday.
We are recommending the federal government finally recognize Canada needs a national Orphan Product Policy to set a standard of equality for Canadians with rare and life-threatening conditions.
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States.
Cell therapy company Cytori Therapeutics Inc (NasdaqCM:CYTX) reported on Monday the receipt of the US FDA Office of Orphan Products Development (OOPD) orphan drug designation for cryopreserved or centrally processed ECCS-50 for scleroderma.
Each national authority has to agree labelling and reimbursement which not only leads to delays in products reaching the market but also in orphan products becoming available in most member states.
M2 PHARMA-December 29, 2016-US FDA's Office of Orphan Products Development grants orphan drug designation to Escend Pharmaceuticals' ES-3000
The FDA Office of Orphan Products Development (OOPD) status indicates that the drug qualifies for the benefits specified in the Orphan Drug Act during development for the designated indication, including tax credits for qualified clinical testing, orphan drug exclusivity, and an exemption from marketing application user fees.
NESS ZIONA, Israel -- Atox Bio today announced that the FDA Office of Orphan Products Development has granted orphan drug designation for AB103 for the treatment of necrotizing soft tissue infections.
The US FDA's Office of Orphan Products Development reportedly provides sponsors with development and commercial incentives, including seven years of market exclusivity in the U.