viernes, 20 de enero de 2017

New Guidances on Medical Product Communication and Multiple Endpoints in Clinical Trials

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

1. FDA announces new draft guidances on medical product communication
FDA announced the release of two guidances related to medical product communications and reopened the comment period for the off-label Public Hearing.
For more information about this release, please see the Statement from FDA Commissioner Robert Califf, M.D.
The guidances and information on the comment period for the off-label public hearing can be found at: 
This guidance provides sponsors and review staff with the Agency’s thinking about the problems posed by multiple endpoints in the analysis and interpretation of study results and how these problems can be managed in clinical trials for human drugs, including drugs subject to licensing as biological products. 

No hay comentarios: