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comment by ButterflyEffect
ButterflyEffect  ·  1428 days ago  ·  link  ·    ·  parent  ·  post: Pubski: April 29, 2020

The FDA is kind of weird in this way. Well, I guess it makes sense on their end to not be overly prescriptive with how to accomplish something. I bet b_b can speak to this too from his perspective, I'm only speaking to interactions I've had with the FDA within the Food & Beverage industry...

    FDA has even said if you're a lab in good standing, whatever that means, and if you validate your test in some magic way, again super vague, that you're fine and don't need anything more. But this specific lab is not EUA approved.

They really don't tell you how to do something unless you bug them about it long enough, and figure out how to bug the right person. This is both good and bad - there's more than one way to do most things, after all, and all that needs to be provided is validation of the effectiveness of the work performed to meet the FDA regulation and guidance. It allows flexibility in manufacturing and in some cases, actual innovation! The downside is...a lot of the time it leaves it up what the fuck are you actually asking me to do!?!? and a lack of trust in the system...





c_hawkthorne  ·  1428 days ago  ·  link  ·  

Yeah my regular job is regulatory. I just tell people they're wrong and they have to fix stuff, but I can't tell them how to fix it, that's up to them. Otherwise we might be playing too hard into their finances which becomes a hairy situation fast. We do conflict of interest paperwork annually and even the year after we leave as well. I don't envy the FDA these days. They're stuck between a rock and a hard place. I'm not saying it's wrong to not say how something has to be done, but they can be less vague about it. That lack of trust... the more I learn about everything the more I feel it.