FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Discusses Pilot Program for Single-Patient INDs

June 7, 2019
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The FDA has launched a pilot program to help patients access needed investigational drugs outside of clinical investigations.

Project Facilitate, part of the agency’s Expanded Access program, features a call center to help oncology providers navigate the process of obtaining permission for their seriously ill patients with no other treatment options left, including clinical trials.

“Access to clinical trials and access to novel therapeutics for patients is still a problem,” said Richard Pazdur, director of the FDA’s Oncology Center of Excellence, at a public workshop on the pilot program last week. “We know that not all oncologists or healthcare providers have the regulatory expertise or resources to navigate these single-patient IND processes.”

The pilot program will give providers a single point of contact to guide them through the expanded access request process, helping them locate IRB resources, find the correct contact at the company that holds the IND for the requested treatment and complete the necessary FDA forms.

A public database tied in with the program also will list information supplied by drug companies, including each company’s policies on expanded access.

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