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.

A restructuring of FDA’s food safety operations includes changes to the agency-wide office that handles all inspections, including those of drug manufacturers. It’s another shift in the delicate balancing of centralized management of ORA with the specific needs and priorities of the different centers.

A restructuring of FDA’s food safety operations includes changes to the agency-wide office that handles all inspections, including those of drug manufacturers. It’s another shift in the delicate balancing of centralized management of ORA with the specific needs and priorities of the different centers.

National Academies report argues that technologies cannot only be evaluated in the context of specific products, and FDA guidance should become both ‘more fluid and targeted.’