FDA guidance machine churns out 8 new documents in less than a week

As the FDA’s urgency around pandemic-related activities begins to recede, the agency has been on a tear over the past week in releasing new drug-related guidance documents, with 8 new ones, including 3 from the ICH on E2B(R3) and others on ulcerative colitis (UC), Crohn’s disease, and using ctDNA as a biomarker in cancer clinical trials.