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draft guidance
Biotech
FDA outlines draft policy on MRD for accelerated approval
The guidance provides recommendations for designing clinical trials that use MRD or CR as endpoints for accelerated approval in multiple myeloma.
Angus Liu
Jan 21, 2026 2:55pm
FDA draft recommends all cancer trials collect OS data
Aug 20, 2025 10:59am
FDA issues draft guidance on clinical trial tissue biopsies
Jan 6, 2025 2:55pm
FDA releases draft guidance on clinical trial diversity
Jun 27, 2024 7:05am
FDA suggests new tests for morcellator tissue containment tools
Jun 22, 2022 6:25pm
FDA ramps up medical device cybersecurity recommendations
Apr 8, 2022 11:50am
