FDA has recently increased its efforts to support the development and approval of cell, tissue, and gene therapy (CTGT) products. This is evidenced by the upswing in CTGT approvals in.
FDA Draft Guidance On "Rare Diseases Considerations For The Development Of Drugs And Biological Products" clinicalleader.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from clinicalleader.com Daily Mail and Mail on Sunday newspapers.
Identifying surrogate endpoints for use in clinical trials that strongly predict clinical outcomes such as improved survival and quality of life is challenging.
Identifying surrogate endpoints for use in clinical trials that strongly predict clinical outcomes such as improved survival and quality of life is challenging.
The ARC Program strives to increase the number of treatments by promoting innovative scientific design, providing a deeper understanding of regulatory policies, and engaging with patients and their advocates, and other rare disease stakeholders.