CDER Director Cavazzoni is promising to increase coordination and collaboration to accelerate broader adoption of innovative clinical trial designs and other approaches to speed drug development. A new "Quantitative Medicine Center of Excellence" illustrates the approach. 

Supporting ‘n of 1’ gene therapy development, the playbook from a Foundation for the National Institutes of Health-backed consortium aims to help investigators who are not traditional product sponsors prepare for meetings with US FDA and IND submissions.

A plan developed by the US FDA biologics center to test ‘Operation Warp Speed’ style communication to support development of gene therapies is launching – and the scope has broadened to include drugs targeting ALS and other neurodegenerative diseases.

It is clear that the next step in the long-term debate over whether and how the US FDA should regulate lab-developed tests will come from the administration and not Congress. But key legislators are ready to move quickly if they can get enough support.

A House hearing on bipartisan drug pricing reform bills continues the intense focus on the role of pharmacy benefit managers. But it also shows continued interest in finding ways to make payment systems work for cutting edge gene therapies.

External report on the US FDA’s response to the opioid epidemic includes detailed recommendations for enhancements to the advisory committee review process. That dovetails with the agency’s ongoing look at how best to use the expert panels.