Information session on the pilot for expert panels' advice for orphan medical devices From European Medicines Agency (EMA) πͺπΊ An upcoming event discussing a pilot program for expert panels' advice on orphan medical devices. Metadata quality: Metadata quality: Data description empty Files documented License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated 2 days ago Other (Public Domain) 0 reuses 0 favorites
New pilot programme to support orphan medical devices From European Medicines Agency (EMA) πͺπΊ Announcement of a new pilot programme aimed at providing support for orphan medical devices. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on August 2, 2024 Other (Public Domain) 0 reuses 0 favorites
Clinical evaluation of orphan medical devices From European Commission πͺπΊ Document focuses on clinical evaluation of orphan medical devices, specifically discussing clinical investigation and evaluation in the context of orphan devices. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on June 25, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Meetings with the Office of Orphan Products Development: Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document provides guidance for industry, researchers, patient groups, and FDA staff on meetings with the Office of Orphan Products Development. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 11, 2024 Other (Public Domain) 0 reuses 0 favorites
ZL100_00_002e_WL Guidance document Orphan Drug From Swiss Agency for Therapeutic Products (Swissmedic) π¨π Guidance document covering orphan drug development and regulation. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated on May 1, 2023 Other (Non-Commercial) 0 reuses 0 favorites
EU/3/16/1818 - orphan designation for treatment of acute liver failure From European Medicines Agency (EMA) πͺπΊ Orphan designation granted for EU/3/16/1818, a treatment for acute liver failure. Metadata quality: Metadata quality: Data description empty Files documented License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on July 14, 2017 Other (Public Domain) 0 reuses 0 favorites
Joint European Medicines Agency (EMA), US Food and Drug Administration (FDA), and Japanese Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) orphan medicinal product workshop From European Medicines Agency (EMA) πͺπΊ A workshop on orphan medicinal products organized by EMA, FDA, MHLW, and PMDA. Metadata quality: Metadata quality: Data description empty Files documented License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on March 28, 2014 Other (Public Domain) 0 reuses 0 favorites
Orphan medical device designation status From Ministry of Food and Drug Safety (MFDS) π°π· This document provides information on the status of orphan medical device designation. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on February 7, 2024 Other (Public Domain) 0 reuses 0 favorites
Orphan and urgent need medical devices From Ministry of Food and Drug Safety (MFDS) π°π· Document discussing specifics of orphan and urgent need medical devices. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on February 7, 2024 Other (Public Domain) 0 reuses 0 favorites
Overview of the Designation System for Orphan Drugs, Orphan Medical Devices, and Orphan Regenerative Medicine Products From Ministry of Health, Labour and Welfare (MHLW) π―π΅ This document provides an overview of the designation system for orphan drugs, medical devices, and regenerative medicine products. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on October 16, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Overview of Orphan Drug/Medical Device Designation System From Ministry of Health, Labour and Welfare (MHLW) π―π΅ Get an overview of the orphan drug and medical device designation system with this informative document. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on October 16, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites