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mostlyclassics

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I' not talking about the cost of the testing, though that too is going to be a huge part of the costs, but the application fees.

The FDA doesn't charge application fees.

If the procedure is at all like NDAs, (new drug applications) you have to sit down with the FDA first and work out exactly what tests they want done, epidemiological studies done, accompanying documentation, etc., etc. And good luck with that, since the Demon Regulations say nothing specific about what they want.
 

CES

optimistic cynic
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The FDA doesn't charge application fees.

If the procedure is at all like NDAs, (new drug applications) you have to sit down with the FDA first and work out exactly what tests they want done, epidemiological studies done, accompanying documentation, etc., etc. And good luck with that, since the Demon Regulations say nothing specific about what they want.


they do charge user fees for some things User Fees particularly drug applications Prescription Drug User Fee Act (PDUFA) though i admit i didn't specifically check whether this would be the case for PMTAs- i'm cynical enough that i bet there will be a fee.
 

the wind

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age verification for that site is 21years- california increased the legal age for vaping :facepalm:
got this from a ejuice thread on here.
Easy to comply with? You gotta be kidding.

In CA, now that e-cig gear has been deemed tobacco by your lovely Governor it falls under jurisdiction of several pre-existing regulations for the sale and distribution of tobacco.

Here's an "easy" one for ya: Do you know what the maximum package weight is for tobacco products that can be sent to California?

Or: Can or can not free samples still be sent to California?

What taxes are now in effect on "tobacco product" e-cigarettes? Who collects those CA taxes?

How is the shipped package to be marked to indicate those taxes have been collected and paid?

Do you know which carriers are - and are not - allowed to deliver these products to CA now?

Easy no - it's going to be a royal PITA.

MBV has said on their blog that this situation is temporary while they are still trying to sort out whateverthehell CA regulations now actually require. If AVA thinks they have the "easy" answer then perhaps they should share it with Mt. Baker. The local CA SFATA chapter may be seeing things as a bit more complicated.
they need to get Arnold back.
 
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