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Dr. Julia Lee: unsigned FDA Form 356h can trigger refuse-to-receive for an ANDA
Summary
Dr. Julia Lee said FDA will refuse to receive an ANDA if Form FDA 356h is unsigned, citing the provision identified in the session as '3 14 1 0 1 d'.
When asked whether the Office will refuse to receive an abbreviated new drug application (ANDA) if Form FDA 356h is unsigned, Dr. Julia Lee replied, "Yes." She cited the provision referenced in the session as "3 14 1 0 1 d" and said an unsigned FDA 356h is a basis for a refuse-to-receive determination.
Dr. Lee pointed attendees to the filing resources discussed in the presentation, including the filing map and filing checklist, and RTR guidances that identify common refuse-to-receive reasons. Applicants should ensure required submission forms are signed to avoid an administrative refuse-to-receive determination.
