In order to commercialize a health care product in the USA, the US FDA would need to approve it. But what is the standard process and how early would a company need to be involved and maybe even get advice? Additionally, the core question remains how could US FDA requirements be aligned with potential payer needs – are there any relationships?
The #marketaccess veterans Dr. Stefan Walzer and Dr. Jamie Cross are discussing the principles as well as some very specific details.
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