Patient organization exploring development of a multi-stakeholder forum on real world evidence that, among other things, could address research questions posed by the Centers for Medicare and Medicaid Services in its national coverage determination for Alzheimer’s drugs.

The announcement of US FDA Deputy Commissioner’s new focus going forward at the agency may not mean what you think it does. The focus shouldn’t be on what Janet Woodcock is not doing – but on the fact that she is staying on at the agency at all.

Medtech Insight caught up again with iRhythm CEO Quentin Blackford about his vision for the company as it plans for the next five to ten years of expansion in the remote cardiac monitoring and arrhythmia diagnostics market.

Former FDA principal deputy commissioner Amy Abernethy says cell and gene therapy is an area primed for improved ‘parallel conversation’ between FDA and CMS on data requirements.