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Agency official gives do's and don'ts for pre‑development meetings
Summary
The presenter advised applicants to focus PDEV meetings on development strategy and targeted b/p study questions, to present supporting preliminary data and avoid review or assessment questions and last‑minute surprises; common denial reasons include vague questions, assessment requests, insufficient data and wrong meeting type.
The presenter urged applicants to use PDEV meetings to discuss product‑development strategy and data that justify proposed approaches, saying applicants should "present some preliminary data with adequate justification to support your proposal." He advised asking targeted, science‑specific questions about bioequivalence (b) and performance (p) study design and warned against bringing new data at the last minute.
On common denial reasons, the presenter listed questions that are too broad or vague, questions that seek an assessment/decision rather than clarification, insufficient supporting data, or products that do not meet the criteria for being complex. He recommended controlled correspondence for narrow or standalone questions that do not require a formal meeting.
