Zdrowie i gospodarka · 21/06/2000

Draft Guidance for Industry: Pediatric Oncology Studies in Response to a Written Request; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Pediatric Oncology Studies in Response to a Written Request." The draft guidance document provides assistance to applicants intending to respond to a written request from FDA for pediatric studies for a drug that may show potential health benefits in children with cancer. The draft guidance discusses the kind of information applicants should include in their pediatric studies, which, if responsive to a written request, may make the applicant's drug eligible to qualify for an additional 6 months of marketing exclusivity. This guidance is part of the agency's pediatric initiative to generate new knowledge to assist practitioners in the care of children with cancer and to help provide pediatric patients early access to emerging new drugs.