FDA PMTA’s

[Vapinginthe410]

Because of the pandemic going on, did they push back the PMTA’s?

 

[Opinionated]

Because of the pandemic going on, did they push back the PMTA’s?

The FDA submitted a request for a 120 day extension on it but I've not heard what the court's decision is...

FDA Submits Request to Court to Extend Premarket Application Deadline

So right now it's all depending on that decision since it was the court which decided the FDA had to comply with deeming requirements now and the FDA decided against taking it to a higher court.

That court is obviously not on our side so who knows?

 

[Vapinginthe410]

The FDA submitted a request for a 120 day extension on it but I've not heard what the court's decision is...

FDA Submits Request to Court to Extend Premarket Application Deadline

So right now it's all depending on that decision since it was the court which decided the FDA had to comply with deeming requirements now and the FDA decided against taking it to a higher court.

That court is obviously not on our side so who knows?

Seems like most judges/politicians aren’t on our side

 

[thanswr1]

E-Cigarette Deadline Extended Amid COVID-19 Pandemic - Law360

 

[WorksForMe]

E-Cigarette Deadline Extended Amid COVID-19 Pandemic - Law360

AFAIK, this is not a done deal yet(though it probably will be). They're still waiting for the 4th Circuit to rule on it before Judge Grimm can extend the deadline.

 

[Opinionated]

E-Cigarette Deadline Extended Amid COVID-19 Pandemic - Law360

The writer of the article you posted wasn't fully understanding the situation.

The District Court issued an "indicative" ruling (simply a ruling indicating what they would do, if the case was in their court), but the Fourth Circuit Court of Appeals still needs to accept the request and then remand the case back to the District Court for the extension, which hasn't been done yet.

Here is an article that offers the explanation far better:

FDA and Federal Court Move Toward Extension of May 12 Deadline for Premarket Review Applications - Lexology

 

[thanswr1]

Thanks all.

Something didn't seem right when the learned sages on this site hadn't posted the good news.

 

[thanswr1]

I think it's a done deal now.

PMTA Deadline Delay Granted