Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA; Draft Guidance for Industry; Availability

PDA agrees that in some cases Human Factors studies may be required to establish that the generic combination product can be substituted for the RLD to users of the current RLD (without additional physician intervention and/or retraining prior to use) without resulting in a level of critical task errors that would represent an unacceptable risk. However, PDA disagrees that the proposed Comparative Human Factors studies are reasonable, appropriate and address all use scenarios (i.e. when nave users are provided the proposed generic). Please see the specific comments and proposals in the attachment.