FDA grants orphan drug status to the beta herpes virus drug Novel Human Cytomegalovirus (HCMV) inhibitor AIC246 (Letermovir) in at-risk patients.
HCMV affects organ and bone-marrow transplant and HIV patients, and the symptoms can include fever, leukopenia, and thrombocytopenia with or without specific organ dysfunction.
The US Food and Drug Administration controls orphan drugs requirements meetings , ethical needs and clinical trials.
Dr. Robert "Skip" Nelson, Senior Pediatric Ethicist and Lead Medical Officer at FDA will be speaking about ethical aspects of clinical trial design at World Pediatric Drugs Congress 2012, co-located at Terrapinn's World Orphan Drug Congress USA, this April.
Come with the business and scientific industry leaders from North America and beyond to North America's leading orphan drug conference to strategize about the opportunities and challenges in commercializing treatments for rare and ultra-rare diseases.
Check the agenda here.
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