FDA meetings, categorized as Type A, Type B, and Type C, are crucial interactions between sponsors and the FDA during drug development.Type A meetings address stalled development or safety issues.Type B meetings are milestone meetings, such as pre-IND or end-of-phase meetings.Type C meetings are for any other development-related topics not covered by A or B.
Type A Meetings: These meetings are for resolving critical issues that are actively blocking the progress of a product's development.They are typically held when a product development program is stalled or to address an important safety concern.For example, a Type A meeting might be needed if a clinical hold is preventing further trials.
Type B Meetings: These meetings are scheduled around specific milestones in the drug development process.They include:
Pre-IND Meetings:
Held before an Investigational New Drug application to discuss the planned clinical trials.
End-of-Phase Meetings:
Held at the end of specific phases of clinical trials (e.g., End-of-Phase 1) to discuss the next steps in development.
Pre-NDA/BLA Meetings:
Held before submitting a New Drug Application (NDA) or Biologics License Application (BLA).
Type C Meetings: This is a broad category for any meeting that doesn't fall under Type A or Type B. These meetings can cover a wide range of topics, including:
Discussions on the use of new biomarkers.
Protocol amendments.
Data interpretation.
Early discussions about therapies, trial designs, or data requirements.
In essence, Type A meetings are about getting things moving again, Type B meetings are about reaching specific milestones, and Type C meetings are about addressing a variety of other development-related issues.
Formal FDA Meetings for Sponsors or Applications of PDUFA Products
26 Feb 2024 — Types of FDA Meetings * Type A FDA Meetings. Type A FDA meetings are "necessary for an otherwise stalled product devel...
ProPharma
FDA guidance on formal meetings adds new categories ...
21 Sept 2023 — Meeting types. The guidance describes the different meeting categories: Type A, B, C and Type D and INTERACT meetings.
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