CDER Issues Guidance Agenda for 2022 Featuring Clinical Trials
The FDA’s Center for Drug Evaluation and Research’s (CDER) guidance agenda for 2022 includes eight draft guidances for clinical trials the center hopes to release before the end of the year.
Topics of trial-related draft guidances on the list include:
- Decentralized clinical trials;
- Using clinical practice data in randomized controlled trials for drugs and biologics;
- Considerations for designing and conducting externally controlled trials for drugs and biologics;
- Determining good cause for noncompliance on periodic status reports required in certain cases for postmarketing studies and clinical trials;
- Inborn errors of metabolism that use dietary management: considerations for optimizing and standardizing diet in clinical trials for drug product development;
- Measuring growth and evaluating pubertal development in pediatric clinical trials;
- Meeting the substantial evidence standard based on one adequate and well-controlled clinical investigation and confirmatory evidence; and
- Use of data monitoring committees in controlled clinical trials.
The annual guidance agenda is more of a wish list for the year than a firm commitment by the center. Five of the eight trial-related draft guidances on this year’s list are carryovers from 2021. The list does not include any final trial-related guidances CDER plans to issue in 2022.
Read the 2022 FDA guidance agenda here: https://bit.ly/3LlPOxJ.