FDA Drug Center Releases 2021 Clinical Trial Guidance Agenda
Several new FDA clinical trial-related guidances are planned for 2021, according to the Center for Drug Evaluation and Research (CDER) guidance agenda released last week.
CDER’s plan for 2021 includes guidances on using multiple endpoints, safety reporting responsibilities for investigators and sponsors, decentralized clinical trials, data monitoring committees and the use of digital health technologies for remote data acquisition in clinical investigations.
The center also will address use of real-world data and real-world evidence, and the use of electronic records and electronic signatures in clinical investigations under 21 CFR Part 11.
CDER did not specify when it will issue the guidances.
Read CDER’s guidance agenda here: https://bit.ly/3acExhE.