On August 22, 2023 our very own Dr. Willie McKinney, CEO, had the opportunity to express his views and opinions […] Read More
3 min. read
Resources
Topic: PMTA
2 min. read
Lucy Goods Submits PMTAs for 42 Nicotine Products
Lucy Goods has submitted premarket tobacco product applications (PMTAs) to the U.S. FDA seeking marketing authorization of 42 of its […] Read More
3 min. read
From MDO to new hope: Could FDA revisit your PMTA?
By Willie McKinney, Ph.D., D.A.B.T. Potential implications of FDA’s October 7, 2021 rescission of its Marketing Denial Order (MDO) issued […] Read More
7 min. read
The FDA gifted you a PMTA deficiency letter … what’s your strategy?
By Willie McKinney and Cheryl K. Olson “I read it. And I thought it was over.” Anne* held the letter […] Read More
1 min. read
PMTA Deficiency Letter Readiness and Response Preparation
Are you anxiously waiting to hear from FDA about your PMTA? Ideally, the next time you hear from the FDA […] Read More
4 min. read
Peeking Around the Corner of a PMTA Submission
by Willie McKinney, Ph.D., DABT Looking ahead after the PMTA submission deadline Although it’s well outside of their purview, the […] Read More
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