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FDA: New PMTA Stats + New Update Page + New Update Method = WTF? (Now with Product-Type Breakdowns!!!) https://ift.tt/3bcfATU

FDA has been playing 3-Card Monty with the updates lately, sometimes updating at Site-1, sometimes at Site-2, and now at the New & Improved Site-2a (which is now a .pdf file, actually).

The original Site-2 was scrubbed of all stats sometime this afternoon. FDA didn't leave any forwarding link to the new update page so I had to search for it – Thanks, dicks.

Previous updates listed "PMTAs Received"; the present update leaves that statistic blank. Instead, FDA is now reporting "PMTAs Accepted", and several other metrics, some new & interesting (like "Deficiency Letters Issued" and "Discipline Reviews Completed").

BIG NEWS:

FDA is now listing the numbers by product-type (ie: Cigarette; Roll-Your-Own; Smokeless; ENDS; Cigars; Pipe; Waterpipe; Other).

Also:

58,532 PMTAs for ENDS products have passed "Acceptance Review" ("Acceptance Review" is "Phase 1" of the approval process). And 27,910 PMTAs for ENDS products have passed "Filing Review" ("Filing Review" is "Phase 2" of the approval process).

FDA isn't listing Phase 3 numbers (Final, "Substantive Review").

Here's the link to the New Update Site Click "View the complete set of PMTA Metrics" for the actual stats (4 page pdf).

EDIT: Turns out, FDA did announce the new update page, in a special "Perspectives" piece from Mitch Zeller, published today Link.

Some interesting new info there:

the initial “intake” of submissions is nearly complete

For PMTAs, as of mid-January 2021, the agency has completed the Processing step of applications for more than 4.8 million products from over 230 companies.

One firm submitted information on more than 4 million tobacco products within a single submission.

We have also commenced substantive review on hundreds of products submitted through the PMTA pathway.

For applications classified as PMTAs, the review order for most of the products is also determined using the same randomization process … However, due to the large number of ENDS products … FDA decided to dedicate a portion of its resources to reviewing the products that account for most of the current market … —as they hold the largest overall market share and therefore likely used by the largest number of people. For this reason, FDA pulled several applications into a separate review queue and dedicated resources to their review.

given the unprecedented number of applications and other factors discussed above, the likelihood of FDA reviewing all the applications by Sept. 9, 2021 is low

[FDA is also working on their big PMTA Whitelist but they've got a long, long way to go and no vapor products are currently listed].

FDA has been playing 3-Card Monty with the updates lately, sometimes updating at Site-1, sometimes at Site-2, and now at the New & Improved Site-2a (which is now a .pdf file, actually).The original Site-2 was scrubbed of all stats sometime this afternoon. FDA didn’t leave any forwarding link to the new update page so I had to search for it – Thanks, dicks.Previous updates listed “PMTAs Received”; the present update leaves that statistic blank. Instead, FDA is now reporting “PMTAs Accepted”, and several other metrics, some new & interesting (like “Deficiency Letters Issued” and “Discipline Reviews Completed”).BIG NEWS: -FDA is now listing the numbers by product-type (ie: Cigarette; Roll-Your-Own; Smokeless; ENDS; Cigars; Pipe; Waterpipe; Other).Also: -58,532 PMTAs for ENDS products have passed “Acceptance Review” (“Acceptance Review” is “Phase 1” of the approval process). And 27,910 PMTAs for ENDS products have passed “Filing Review” (“Filing Review” is “Phase 2” of the approval process).FDA isn’t listing Phase 3 numbers (Final, “Substantive Review”).Here’s the link to the New Update Site Click “View the complete set of PMTA Metrics” for the actual stats (4 page pdf).EDIT: Turns out, FDA did announce the new update page, in a special “Perspectives” piece from Mitch Zeller, published today Link.Some interesting new info there:the initial “intake” of submissions is nearly completeFor PMTAs, as of mid-January 2021, the agency has completed the Processing step of applications for more than 4.8 million products from over 230 companies.One firm submitted information on more than 4 million tobacco products within a single submission.We have also commenced substantive review on hundreds of products submitted through the PMTA pathway.For applications classified as PMTAs, the review order for most of the products is also determined using the same randomization process … However, due to the large number of ENDS products … FDA decided to dedicate a portion of its resources to reviewing the products that account for most of the current market … —as they hold the largest overall market share and therefore likely used by the largest number of people. For this reason, FDA pulled several applications into a separate review queue and dedicated resources to their review.given the unprecedented number of applications and other factors discussed above, the likelihood of FDA reviewing all the applications by Sept. 9, 2021 is low[FDA is also working on their big PMTA Whitelist but they’ve got a long, long way to go and no vapor products are currently listed].

Submitted February 17, 2021 at 03:50AM by M_Onan_Batterload
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