ANDA Human Factors Guidance

#1
Quick Question,

The current draft guidance for Human Factors related to ANDA's and also overall Combination products seems to read a little ambiguous to me and has maybe a little too much room for interpretation when considering generics and RLD's.

The way I'm reading the guidance is that HF Studies are not required for ANDA's if there are no design differences between the generic and RLD. If there are differences, a Comparative Use study is deployed for HF Validation and it may be prudent to perform a formative studies (comparative or not) to help inform design decisions and to de-risk development ahead of getting into HF Validation Studies. These various activities are ultimately driven by the outcomes of risk and threshold analysis.

Are other's interpreting the Agencies guidance similarly to me or am I missing something here?
 
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