ImClone Erbitux Hearing Will Include Five FDAers Under Subpoena
Executive Summary
The House Energy & Commerce/Oversight Subcommittee has subpoenaed five FDA witnesses to appear at a June 13 hearing on issues surrounding the refuse-to-file letter for ImClone's Erbitux
You may also be interested in...
Unresolved Review Issues: Clinical Trials Are Easier Fix Than Safety, Efficacy
Problems with clinical trial design and/or execution identified pre-submission are the issues most likely to be resolved in advance of first FDA action, Booz Allen Hamilton's first-cycle review report finds
Erbitux Oncologic Potential Endorsed By FDA, Bristol During House Hearing
ImClone's oncologic agent Erbitux is "an active anticancer agent," Bristol-Myers Squibb and FDA Oncologic Drug Products Division Director Richard Pazdur, MD, agreed during a June 13 Energy & Commerce/Oversight Subcommittee hearing
Erbitux Oncologic Potential Endorsed By FDA, Bristol During House Hearing
ImClone's oncologic agent Erbitux is "an active anticancer agent," Bristol-Myers Squibb and FDA Oncologic Drug Products Division Director Richard Pazdur, MD, agreed during a June 13 Energy & Commerce/Oversight Subcommittee hearing