Zdrowie i gospodarka · 10/10/2019

FDA Announces Final Guidance for Streamlined Submission Process for Investigational In Vitro Diagnostics in Oncology Trials

The FDA has released a final guidance for industry on a streamlined process for determining the risk of investigational in vitro diagnostics in oncology clinical trials, allowing sponsors to submit all relevant information to the IND application for review by CBER and CDER or CDRH.