US : FDA consults on procedures for transferring approved studies to another IRB

摘要

The US Food and Drug Administration has issued a draft guideline explaining the various factors that drug and medical device companies should consider when transferring the oversight of a previously-approved clinical investigation to another institutional review board.The guidance has been developed in partnership with the Office for Human Research Protections and it addresses many questions that drug and device companies have raised over the years concerning the procedures and processes that are required or recommended by the FDA/OHRP when such oversight is transferred.