Orphan Medical Products

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Medical products for rare diseases and conditions | FDA

https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions

The Orphan Products Grants program provides funding for clinical trials and natural history studies to help advance rare disease medical product development. The Pediatric …

Orphan medicinal products - Public Health

https://health.ec.europa.eu/medicinal-products/orphan-medicinal-products_en

Orphan medicinal products are intended for the diagnosis, prevention or treatment of life-threatening or very serious conditions that affect no more than 5 in 10,000 people in the …

Office of Orphan Products Development | FDA

https://www.fda.gov/about-fda/office-clinical-policy-and-programs/office-orphan-products-development

Phone: 301-796-8660 Office of Orphan Products Development Office of Clinical Policy and Programs U.S. Food and Drug Administration 10903 New Hampshire …

Committee for Orphan Medicinal Products (COMP)

https://www.ema.europa.eu/en/committees/committee-orphan-medicinal-products-comp

The Committee for Orphan Medicinal Products (COMP) is the European Medicines Agency's (EMA) committee responsible for recommending orphan designation …

Orphan Products: Hope for People With Rare Diseases

https://www.fda.gov/drugs/information-consumers-and-patients-drugs/orphan-products-hope-people-rare-diseases

An orphan disease is defined as a condition that affects fewer than 200,000 people nationwide. This includes diseases as familiar as cystic fibrosis, Lou Gehrig's disease, …

Orphan designation: Overview | European …

https://www.ema.europa.eu/en/human-regulatory/overview/orphan-designation-overview

The European Medicines Agency (EMA) plays a central role in facilitating the development and authorisation of medicines for rare diseases, which are termed 'orphan medicines' in the medical …

Orphan drug - Wikipedia

https://en.wikipedia.org/wiki/Orphan_drug

An orphan drug is a pharmaceutical agent developed to treat medical conditions which would not be profitable to produce without government assistance due to the small …

About Orphan Products Clinical Trial Grants | FDA

https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/about-orphan-products-clinical-trial-grants

Orphan products are drugs, biologics, medical devices, and medical foods that are indicated for a rare disease or condition. Rare diseases, as generally defined in the US …

Products - Orpharma

https://www.orpharma.com/products/

Products - Orpharma Products Pharmaceuticals Overview A diverse portfolio of pharmaceuticals focused on addressing unmet demands. Our current range includes …

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