Katrina’s Blog™

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on the science and technology of drugs and medical devices, including discovery, development, manufacturing, and regulation.

Expanded Access Made Easier for Oncology Treatments

June 27, 2019
| Uncategorized

On June 3rd the FDAs Oncology Center for Excellence announced the launch of a new call center known as Project Facilitate to increase access to unapproved oncology therapies for use in patients who are not eligible for the clinical trial(s) for those therapies. Readers will recall my previous post on the Expanded Access program as a means for physicians to request access to new products for their critical care patients. The new call center will streamline the process for to make requests to treat their patients and will enable the agency to collect data to enable improvements to the Expanded Access program. Along with recent guidance on broadening clinical trial eligibility, the call center should enable physicians to get their critical patients access to novel new therapies. Read more about Project Facilitate at this web page

Text Copyright © 2019 Katrina Rogers

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