Commissioner Gottlieb Reports FDA Easing on Expanded Access INDs; Addresses Sponsor Reluctance

According to Commissioner Gottlieb, “Each year, FDA receives over 1,000 applications for the treatment of patients through expanded access, also known as compassionate use, and the agency authorizes the vast majority (about 99%). FDA recognizes that time is critical for these seriously ill patients who do not have alternative therapies, and who cannot take part in a clinical trial of an investigational therapy.”

New Form, Reduction in IRB Burden Among Changes
“FDA streamlined the expanded access process by introducing a new application form which a physician may use to request expanded access for their patient. Form FDA 3926 reduced the number of required information fields and attachments… I’m announcing today that just one IRB member – the chair or another appropriate person – can now approve the treatment…”

Addresses Concerns
“We’ve seen some reluctance among companies to provide investigational drugs for expanded access… To clarify how adverse event data in these circumstances are viewed, we’ve updated the guidance for industry entitled, ‘Expanded Access to Investigational Drugs for Treatment Use.’” Click here for the full story, here for the updated guidance or here to contact PDG for help with your meeting with FDA or regulatory submission.

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