Draft Regulatory Science Research Needs - 2024 update

Shortage of Ixiaro (Japanese encephalitis vaccine (inactivated, adsorbed))

Orphan designation: Atacicept Treatment of primary IgA nephropathy, 10/11/2024 Positive

Orphan designation: 3-(5-(2-Hydroxy-2-methylpropoxy)-6-methylpyrazin-2-yl)-1H-indole-7-carbonitrile Treatment of X-linked spinal and bulbar muscular atrophy (Kennedy's disease), 10/11/2024 Positive

Orphan designation: 4,9-Dimethyl-6-(4'-aminophenyl)-2H-furo[2,3-h]-1-benzopyran-2-one Treatment of cystic fibrosis, 10/11/2024 Positive

Orphan designation: Interleukin-12, human, recombinant Treatment of cutaneous T-cell lymphoma, 10/11/2024 Positive

Social Media Data for Real World Evidence in Regulatory Decision Making

CTIS newsflash - 19 November 2024

Template - Request for advice on the clinical development strategy or clinical data required for the clinical evaluation pursuant to Article 61(2) or Article 106(11) of Regulation (EU) 2017/745 and MDCG 2024-10 on from the Expert Panels

Template - Request for advice on the orphan device status pursuant to Article 61(2) of Regulation (EU) 2017/745 and MDCG 2024-10