Type A Meeting

FDA Meetings & Communication

An FDA formal meeting category intended to address urgent, program-stalling issues (e.g., clinical hold, dispute resolution, post-action).

FDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products (2023)

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Type A Meeting

FDA Meetings & Communication

An FDA formal meeting category intended to address urgent, program-stalling issues (e.g., clinical hold, dispute resolution, post-action).

FDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products (2023)