Preclinical studies and clinical trial designs for products addressing neglected tropical diseases are among the topics slated for discussion at a public hearing organised by the US Food and Drug Administration for early autumn.
The FDA has set a date of 22 September for the hearing on “issues related to advancing the development of medical products (drugs, biological products and medical devices) used in the prevention, diagnosis and treatment of neglected tropical diseases”.
Other key issues to be tackled at the hearing include perceived challenges in securing pre-market approval for neglected tropical disease products; the benefits or otherwise of orphan status, priority review vouchers and humanitarian device programmes; new strategies for international co-operation, consultation and collaboration in the review and approval of neglected disease products; and training or guidance needed to support product development in the field.
As the FDA points out in a Federal Register notice announcing the hearing, Section 740 of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriation Act of 2010 directs the agency to set up a review group that will recommend to the FDA Commissioner “appropriate preclinical studies, trial design, regulatory approaches and optimal solutions” to encourage the development of neglected tropical disease products.
The 22 September hearing will help to inform this process, the agency says. To date, it observes, the development of medical products to prevent, diagnose and treat neglected tropical diseases “has not met global public health needs due to an array of challenges”.
