Regulatory
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Holly started the discussion BDR or Pre-Sub? in the forum Regulatory 7 weeks ago
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…
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Holly posted an update in the group
Regulatory 8 weeks agoDoes anyone know why we can no longer see 510k summaries in the 510k database? I am even trying old ones that I know I have pulled recently and they are all missing…
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I swear I looked at some this morning and now they are not there. Any updates?
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Not definitively – based on a some folks I have talked to we think its just maintenance things? Fingers crossed – if this was intentional I would hope they would release something about it.
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