Industry has been slow to embrace the idea of pragmatic clinical trials with streamlined data collection, so the Oncology Center of Excellence now is turning to the broader cancer community for research proposals.

Compliance functions will be moved to the product centers when ORA becomes the Office of Inspections and Investigations, and centers will become responsible for making the final agency decision on inspection classifications, Associate Commissioner Michael Rogers said.

Recent Office of Prescription Drug Promotion enforcement letters provide several learnings, including the need to be aware of a product’s regulatory history and competitive landscape when developing promotions that are consistent with FDA-labeling, experts said.

FDA seeks feedback at 13 June virtual hearing on three general topics related to advisory committees: panel composition, barriers to service for Special Government Employees, and public perception and understanding of the process.

Compliance functions will be moved to the product centers when ORA becomes the Office of Inspections and Investigations, and centers will become responsible for making the final agency decision on inspection classifications, Associate Commissioner Michael Rogers said.

The new tool provides a way of quantifying the degree of diversity by race/ethnicity, sex and age in clinical trials, but the results will not factor into the US health technology assessment body’s cost effectiveness determinations for new drugs.