The FDA would only withdraw a rare disease gene therapy for “pretty clear” reasons, such as when there is minimal benefit with extensive side effects. The one-and-done nature of administration also makes withdrawal easier, CBER Director Peter Marks says.

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.