This is very interesting. I had never heard of it so thank you for bringing it up. In respect to your question, all biologics fall into the CBER department. The regulation process required for the FDA would be IND, Phase 1,2,3 or pivotal trials and then BLA (Biologics License Application). As Dr. Simon explained in the lecture, in BLA clinical data is almost always required because the FDA wants to make sure every works as plan and protect the public. I would say that this type of product would have to go to panel because it would be relatively new in the market and therefore everybody would be new to the safety and efficiency of this murderless meat.

On a side note, I think that if this product passed all the required tests by the FDA, it would have to be very well advertised (more than normal) because people would feel curious about how it was created and what are the consequences of eating it.

Let me know what you think!

Sincerely,
RP.