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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 Drug Designation program provides orphan status to drugs and biologics which are ... program designates medical devices that are intended to treat or diagnose …
Office of Orphan Products Development | FDA
- https://www.fda.gov/about-fda/office-clinical-policy-and-programs/office-orphan-products-development
- Work with sponsors to determine if their products meet the criteria for certain categories (e.g., orphan drug, rare pediatric disease drug or humanitarian use device …
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 …
Orphan Products: Hope for People With Rare Diseases
- https://www.fda.gov/drugs/information-consumers-and-patients-drugs/orphan-products-hope-people-rare-diseases
- Medical Devices; Radiation-Emitting Products ... the disorder and more than 6,000 other rare or "orphan" diseases are receiving increasing attention from the government, patient …
Orphan Medical Devices and Pediatric Cardiology – …
- https://link.springer.com/article/10.1007/s00246-022-03029-1
- Although it is very detailed, with 123 Articles and 16 Annexes, the MDR does not include any special pathways for the regulatory approval of orphan medical devices. …
Orphan medicinal products - Public Health
- https://health.ec.europa.eu/medicinal-products/orphan-medicinal-products_en
- Orphan medicinal products. Orphan medicinal products are intended for the diagnosis, prevention or treatment of life-threatening or very serious conditions that affect no more …
Orphan Devices for the Surgical Treatment of Patients with Rare ...
- https://www.rarediseasesjournal.com/public/articles/orphan-devices-for-the-surgical-treatment-of-patients-with-rare-diseases-present-status-and-recommendations-for-the-future.html
- Text. Orphan devices are medical devices intended for the treatment of a very rare life-threatening or chronically debilitating condition. Several institutions (United States Food …
Medical Devices for Orphan Diseases | CRO | ICON plc
- https://www.iconplc.com/therapeutics/medical-device/orphan-diseases/
- Medical Device. Bio-engineered and Tissue Engineering; Blood Banking; Cardiovascular; Dental and Maxillofacial Devices and Diagnostics; Diabetes Management; Diagnostic …
Orphan Medical Devices and Pediatric Cardiology – …
- https://link.springer.com/content/pdf/10.1007/s00246-022-03029-1.pdf
- orphan medical devices would apply to many technologies used in pediatric cardiology. For example, the prevalence of transposition of the great arteries is < 1 in 3000, and that …
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