Orphan drug

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Related to Orphan status: Orphan Drug Act
Any drug, biological, medical device, or food of potential or actual use in treating ‘orphan’ diseases—diseases regarded by the pharmaceutical industry as too rare for developing commercially viable products

orphan drug/product

Any drug, biological, medical device, or food of potential or actual use in treating 'orphan' diseases–diseases regarded by the pharmaceutical industry as too rare for developing commercially viable products. See Orphan disease. Cf Pseudoorphan drug.

Orphan drug

A term for a drug that treats a rare disease, defined by the Food and Drug Administration (FDA) as one that affects fewer than 200,000 Americans. The FDA has an Office of Orphan Products Development (OOPD), which offers grants to researchers to develop these products.
References in periodicals archive ?
To evaluate the association between orphan status and a detectable viral load at 12 months on ART, researchers used binomial regression analysis with a modified Poisson distribution, clustered by facility.
In multivariable logistic regression analysis, age, sex, duration of stay, suicidal ideation, medical illness, orphan status, and physical abuse maintained association with the outcome variable.
The more contentious issue is whether the UK Government will continue to observe certain EU-wide principles which allow ongoing acceptance of the orphan status of works, within and without the UK, as well as features which would ameliorate future cross-border transactions.
There was a significant relationship between adherence and patient educational level (p = 0.004), duration of treatment (p = 0.001), drug administrator (p = 0.005), and orphan status (p = 0.001).
Orphan status is measured at the binary level with those who had lost both or either of their parents constituting one category and those who had both parents alive constituting another category.
We used data from the Malawi Longitudinal Study of Families and Health (MLSFH).* This data set has several important features that enabled us to address our research questions, notably information on a variety of key variables --including orphan status, time since parental death, and actual and desired fertility--for both women and men.
In general, many indications that would qualify for orphan status are serious or life-threatening conditions which might also qualify for expedited designations.
"Orphan status diseases are an increasing area of therapeutic and commercial focus by the mainstream pharmaceutical industry due to the distinct regulatory and market exclusivity advantages that orphan drug designation confers.
Stuart Needleman, president and chief operating officer of Aptuit, said, "Because of the drug's orphan status and the high unmet medical need of patients, on-time and in-full delivery of the API is crucial.
About 40% of The British Library's (BL) 150 million works have orphan status. Ben White, head of intellectual property at the BL, says, "I certainly believe that once the directive is transposed into member state laws, the directive will help European cultural establishments digitize discrete parts of their collections.
Cultural works - photos, films, works of literature, etc - granted orphan status, ie whose copyright holders cannot be found, may be made public throughout the EU in digital form but only for non-lucrative purposes.
This orphan status is quite comparable to the labeling of federally recognized tribes as wards of the state when Chief Justice John Marshall deemed them "domestic dependent nations" in 1831.