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Industry asks why NDAs fail first-cycle; FDA urges clearer PSGs and proactive engagement
Summary
A former FDA reviewer asked why new drug applications (NDAs) sometimes miss first-cycle approval despite following PSGs; agency panelists said reasons include missing details in submissions and insufficient communication and urged more specific PSGs and cross-disciplinary meetings to reduce review cycles.
A participant who identified themselves as a former FDA reviewer asked why some NDAs do not obtain first-cycle approval even when sponsors followed product-specific guidances and conducted bioequivalence testing. The attendee said review cycles sometimes exceed GDUFA timeframes and asked whether industry or the agency bears responsibility.
An agency panelist responded that there is no single answer but emphasized that clearer PSGs and better communication can reduce avoidable deficiencies. "Sometimes certain deficiencies company get not because the studies cannot be done, simply because they were not aware of the expectations," the speaker said, urging sponsors to "proactively engage with the agency" through meetings and available pathways.
The panel described multiple causes: incomplete presentation of analytical methods or study details, ambiguity in proposed alternative approaches, and the need for coordinated, cross-disciplinary input (e.g., device expertise or human factors when a submission involves a device component). Officials urged companies to use controlled correspondence, multidisciplinary meetings and other engagement tools to clarify expectations and reduce review cycles.
