orphan drug

(redirected from Orphan Product)
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or′phan drug′

a drug that remains undeveloped or is neglected because of limited potential for commercial gain.
References in periodicals archive ?
Senator Orrin Hatch, R-Utah, the senior Republican in the United States Senate, introduced the Orphan Product Extensions Now Accelerating Cures and Treatments Act (OPEN ACT) of 2017.
SPK-9001 has received breakthrough therapy and orphan product designations from the U.
The FDA has designated ProHema an orphan product, which gives is a longer period of sales exclusivity.
The Rare Diseases Orphan Product Development Act of 2002 increased the funding for FDA's Orphan Products Research Grant Program to $25 million, putting more money toward development of therapies for rare diseases.
On the other hand, the drawback of basing a clinical dossier on a limited amount of data is the obvious difficulty in evaluating the safety profile of an orphan product with sufficient statistical confidence.
Chemet is a designated orphan drug supported by the FDA's Orphan Product Development Program.
They oppose the initiatives by Senators Kennedy and Hatch to amend the law, because companies might be deprived of the fruits of their large investments in orphan product R & D.
director of FDAs Office of Orphan Product Development, within the Office of Special Medical Programs.
The ODA provided 7 years of market exclusivity and expanded tax credits for companies developing and marketing orphan drugs, established an Office of Orphan Product Development at the Food and Drug Administration (FDA), and created the Orphan Products Grant Program.
Ann Arbor, MI announced the FDA has granted orphan product status to the company's SC-1 autologous bone marrow stem cells using its AastromReplicell System.
The legislation would give statutory authority to the existing Office of Rare Diseases at NIH and increase federal funding for the ORD and for the FDA's Orphan Product Research Grants program.
The FDA granted Vonvendi orphan product designation for these uses.