As many of us know, conflicts of interest are becoming ever more complex and increasing as various translational activities are encouraged. In many cases, our transitions to remote work and virtual platforms for information sharing are driving this complexity. Read more
While the FDA and OHRP share a mission in protecting volunteers in research, the FDA has a unique responsibility as a public health and consumer protection agency. The dual mission is reflected in the purpose for Investigational New Drug and Investigational Device Exemption regulations which propose to assure safety and rights of subjects, permit evaluation of a drug’s safety and effectiveness, and encourage discovery and development of useful devices intended for human use. Read more
