FDA’s ‘Project Interface’ to provide outreach and engagement
Tanja Obradovic, Vice President of Oncology Scientific Affairs at ICON PLCh, shared a post on LinkedIn:
“Great news for cancer patients, patient advocacy organizations and oncology experts who are keeping in close contact with FDA cancer drug policies.
FDA’s Oncology Center of Excellence (OCE) just opened outreach and engagement initiative named “Project Interface” with a goal to provide direct engagement option with FDA for public to share critical information related to cancer awareness and treatment options. Patient advocacy groups, faith-based organizations, and professional organizations can now contact FDA to request a meeting.
Truly great development toward increased transparency around cancer patient experience, raising public awareness and in general better balance between voice of Industry vs voice of the practicing and patient community at the FDA.
Should we expect the meeting with cancer patients and advocacy representatives whenever new cancer treatment option is undergoing review for approval?
Would such meeting help in minimizing approvals of drugs with marginal efficacy benefit and substantial toxicity that are still deemed clinically meaningful by Sponsors?
This new initiative truly opens important venue for US patients and advocacy groups and highlights important role they can play by engaging much more than in the past with regulators.”
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