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It is crucial for biosimilar developers to engage early and often with FDA to ensure the health authority is well-informed and supports your planned development path. Regulatory meetings and interactions provide sponsors the opportunity to receive valuable feedback along the development process, which can reduce costs, regulatory risks, and time to approval.
To schedule a meeting with FDA, developers must decide on their preferred format, and submit a formal meeting request and informational package. Once the FDA has evaluated the meeting request, they will determine whether to grant the meeting and specify the meeting format. By understanding the FDA meeting types for biosimilar products and their respective timing parameters, biosimilar developers can effectively navigate the regulatory process and optimize their interactions with the health authority.
Learning Points
- Types of FDA meetings for biosimilar products under BsUFA (e.g., BIA and BPD Type 1, 2, 3, 4)
- Meeting applicability, examples, and timing parameters
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