On May 17, the U.S. Food & Drug Administration (“FDA”) issued two important draft guidance documents, which clarify the agency’s approach to requirements and incentives in the realm of pediatric drug development — “Regulatory Considerations Guidance”[1] and “Scientific Considerations Guidance,”[2] respectively. These guidance documents replace FDA’s previous draft guidance on the subject,[3] issued in 2005, and clarify requirements and recommendations for brining pediatric drugs to market. FDA will be accepting public comment on the Regulatory Considerations Guidance and Scientific Considerations Guidance through July 17 of this year.[4]
Continue Reading FDA Clarifies Approach to Pediatric Drug Development
