JD Supra

FDA Issues Guidance on Modernizing Statistical Methods for Clinical Trials

In a new draft guidance issued on January 14, 2026, the FDA discussed the use of a modern statistical methodology in clinical trials designed to ...
Targeted Oncology

FDA Issues Draft Guidance on MRD and CR End Points in Multiple Myeloma

The FDA released a draft guidance document that provides a regulatory framework for sponsors to utilize minimal residual disease (MRD) and complete response (CR) as primary end points in clinical ...
JD Supra

FDA’s 2026 CDS and General Wellness Guidance Updates

For companies developing digital health products, wearables, or software-enabled devices, FDA’s latest guidance updates ...
The American Journal of Managed Care

FDA Draft Guidance Proposes CR, MRD to Accelerate MM Drug Approval

The FDA draft guidance recommends MRD and CR as endpoints for accelerated drug approval in multiple myeloma, emphasizing ...
Becker's Hospital Review

FDA Issues Draft Regulatory Guidance on New Breast Cancer Drug Trials Design

The Foundation for the National Institutes of Health announced the Food and Drug Administration’s draft of regulatory guidance on a new design for conducting breast cancer drug trials. The new ...
BioSpace

FDA’s Multiple Myeloma Guidance Highlights Decade of Success

New draft guidance from the FDA on multiple myeloma endpoints reflects the new technology available to assess disease and how patient journeys have changed with better treatments.