PMTA
RESOURCES

QUICK LINKS

Sourced directly from the FDA and CTP websites. View current submissions, market authorizations, and warning letters.

INFORMATIONAL
RESOURCES

For additional resources be sure to look at the insights page where BRS releases information in regards to FDA PMTAs and other industries.

5 THINGS YOUR PMTA NEEDS

“With the recent issue of the new Final Rule, it is now clear what components are necessary to build a PMTA that will get to the critical substantiative review in FDA’s extensive application process…”

TAKEAWAYS FROM FDA PMTA PROGRESS REPORT

“FDA spent years preparing for the thousands of applications they received and hired additional staff for processing the onslaught of data. While the review is still in progress..”

PMTA PROCESS – UNDERSTANDING THE STATUSES

“If you’re following PMTA submissions, you’ve probably seen many press releases from vape companies detailing the status of their applications…”

PMTA RESEARCH GUIDANCE
‎

“this guidance offers a window into FDA’s thought process as they review current ENDS PMTAs (Electronic Nicotine Delivery Systems…”