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Grace Moser

Latest From Grace Moser

US FDA Drugs Center Ready To Break Down Silos On Regulatory Innovation

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. 

FDA Regulatory

Bespoke Gene Therapy ‘Playbook’ Outlines Platform Approach To AAV-Based Treatments

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.

Gene Therapy Clinical Trials

‘Warp Speed’ For Rare Diseases: Gene Therapy Pilot Also Includes Neurodegenerative Drugs

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.

Rare Diseases Review Pathway

US FDA Diagnostic Test Regulation Bill Stays On Back Burner

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.

Diagnostics Legislation

Drug Pricing Reforms In US Congress: Legacy Systems vs. Cutting-Edge

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.

Pricing Debate Politics

FDA Opioid Review Adds Another Push For Advisory Committee Overhaul

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.

Drug Approval Standards Advisory Committees
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