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Chief Medical Officer Summit -CMO 360°
Meet the Veristat team at Booth #3, April 17th and 18th in Boston
The Science-First CRO™ and Consultancy Ready to...
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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
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Apr 9, 2024 Veristat Events
Meet the Veristat team at Booth #3, April 17th and 18th in Boston
The Science-First CRO™ and Consultancy Ready to...
4 min read
Mar 22, 2024 Veristat Events
Don´t miss Veristat’s plenary presentation at the World Orphan Drug Congress (WODC), Boston, Thursday, April 25th at...