2005N-0285 Current Good Manufacturing Practice Regulation and Investigational New Drugs
FDA Comment Number : EC1
Submitter : Ms. Beth Incao Date & Time: 02/08/2006 10:02:19
Organization : Ms. Beth Incao
Category : Federal Government
Issue Areas/Comments
In regards to exempting investigational Phase I drugs from complying with Part 211, I feel that this is misleading and unclear. The proposed change states that a Phase I drug which will be used in future Phase II or III studies must comply with Part 211 yet at many times, this knowledge is not known during Phase I studies. The Sponsor will more than likely opt for the situation of abiding by Part 211 during Phase I rather than not being able to use data from those trials for Phase II and III studies. I would propose that rather than exempting Phase I trials completely from the regulation to instead require a lesser degree of the regulation for compliance. In addition, proposing that only certain Phase I drugs follow cGMPs while others are exempt promotes a situation where subject safety may be at risk.