Docket Management
Docket: 02D-0094 - Draft Guid.: IND Exemptions for Studies of Lawfully Marketed Cancer Drug or Biological Products
Comment Number: EC -1

Accepted - Volume 1

Comment Record
Commentor Dr. Roy Jones Date/Time 2002-05-20 14:56:02
Organization MD Anderson Cancer Center
Category Academic

Comments for FDA General
1. General Comments I certainly agree that clarification of the IND Exemption guidelines are useful. There is considerable ambiguity, however in guideline #3 (the no significant increase in risk) guideline. The question is: compared to what? As a bone marrow transplant (BMT) physician, for example, this question is critical. If the new regimen comparison is to be made to alternative standard high-dose regimens, no significant risk increase might be anticipated. Alternatively, if an approved drug is to be tested in higher dose and the comparison is to be made to conventional, lower doses of the agent, a higher risk would always be assumed and an IND always required. If in this clarification you wish to avoid more IND submissions, your intent with this aspecti of the regulation needs to be clarified. Respectfully, Roy B. Jones PhD MD

EC -1