HHS published final guidance providing a checklist identifying regulatory requirements for IRB-written procedures and providing recommendations on the type of information to include. Read More
HHS issued a proposed rule that would delay its revisions to the Common Rule for another six months and opened up discussion on the permitting of three burden-reducing provisions in the 2018 requirements for regulated entities. Read More
The FDA released two final guidance documents related to next-generation sequencing (NGS) and one draft guidance on investigational in vitro diagnostics (IVDs) in oncology trials. All three documents offer test developer recommendations for a more efficient path to market. Read More