The Food and Drug Administration (FDA) has announced the availability of a draft guidance for industry entitled “General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products.” Comments requested by February 9, 2015.
The first session “Complexities in Evaluating Human Clinical and Observational Data for Ingredient Safety Assessment: Partially Hydrogenated Oils (PHOs) As a Case Study” will be November 7, 2014. This event also accessible by webcast.
NIH will accept responses through October 13, 2014. FASEB is working with the Animals in Research and Education Subcommittee and the Clinical and Translational Research Subcommittee to develop a letter to be sent to NIH on balancing sex in research.