Regulatory
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BDR or Pre-Sub?
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BDR or Pre-Sub?
Hi everyone, I have a client where I am trying to decide whether to recommend a BDDR or a pre-submission first. They will need another pre-submission eventually as their submission requires a GLP animal study and potentially another clinical study (and in their last pre-sub the FDA asked them to present their substantial equivalence table so they could provide feedback related to viability of a 510k pathway). I will say the technology is quite novel and preliminary clinical data is excellent. Currently their biggest question is whether they need to do De Novo or 510k (my gut says De Novo but I’d rather let the FDA tell us that after we put forward our best effort at a 510k strategy) which would make me lean towards just pre-submission. BUT I do think they have a shot at BDD, and given they have to propose a regulatory pathway in the framework of that submission request, am wondering if BDDR first make more sense (two birds, one stone).
Thoughts?!
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