Perspective: FDA’s Preparations for the September 9 Submission Deadline

[5150sick]

FDA’s Preparations for the September 9 Submission Deadline

On Sept. 9, premarket review applications for many new tobacco products are due for review

www.fda.gov

 

[MarkS]

Reading this just made my blood pressure go through the roof. What a freaking travesty.

 

[BobsHere]

What about this part? May delay enforcement is what I read. Sellers may continue to sell until enforcement?

Looking Forward

Consistent with the court order that set the Sept. 9, 2020 application deadline, for products with timely applications, FDA may continue to defer enforcement of the premarket requirements for up to one year through Sept. 9, 2021 (unless a negative action is issued by the FDA on an application during that time). Examples of negative actions include Refusal to Accept (RTA), Refusal to File (RTF), and a No Marketing Order (NMO)

 

[BobsHere]

What about this part? May delay enforcement is what I read. Sellers may continue to sell until enforcement?

Looking Forward

Consistent with the court order that set the Sept. 9, 2020 application deadline, for products with timely applications, FDA may continue to defer enforcement of the premarket requirements for up to one year through Sept. 9, 2021 (unless a negative action is issued by the FDA on an application during that time). Examples of negative actions include Refusal to Accept (RTA), Refusal to File (RTF), and a No Marketing Order (NMO)

I think I can answer you Bob, I know you're a little slow sometimes and you think you can speed read but ya can't...
That's for products with timely applications, says so right there... ?

 

[MarkS]

And, the part where they did a 10x increase in employment. Building the Empire.