The FDA updated its meeting practices to permit companies to send a single follow-up email to clarify one question after official meetings. The agency said the measure aims to reduce ambiguity and speed development by giving sponsors a narrow channel to confirm interpretive points without reopening formal correspondence protocols. The change affects a broad range of biopharma interactions with the agency—from pre-IND and end-of-Phase-2 consultations to Type B and C meetings—potentially reducing back-and-forth and accelerating decision timelines. Regulatory teams see the move as pragmatic: it formalizes an oft-requested capability while preserving the meeting record. Implementation details—such as timing windows and allowable content—will determine practical benefits. Companies expect modest near-term efficiency gains for complex programs where a single clarification can materially affect regulatory strategy or CMC planning.
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