FDA PMTA Denial Orders
(Updated 11/03/2021)

Published November 3rd, 2021

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FDA PMTA Warning Letters
(Updated 11/03/2021)

Published November 3rd, 2021

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Differences in US FDA Medical Device Classifications

Published October 19th, 2021

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FDA PMTA Marketing Granted Orders
(Updated 10/19/2021)

Published October 19th, 2021

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FDA PMTA Warning Letter Closeouts
(Updated 09/09/2021)

Published September 9th, 2021

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What FDA’s Recent PMTA Denials Mean for the E-Cigarette Industry

Published September 9th, 2021

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The FDA Deficiency Letter Response Process for Premarket Tobacco Applications: How to Survive Substantive Scientific Review
Published June 10th, 2021

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FDA Releases Long-Awaited PMTA Submissions List
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Published May 20th, 2021

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The Increasing Importance of Finding Validated Labs
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Published April 8th, 2021

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FDA Warns Against Fake Certification for Face Masks
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Published March 11th, 2021

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How BRS’s Consumer Level 1 Facemasks Compare to the New ASTM Barrier Mask Standard
Published February 25th, 2021

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Key Takeaways From FDA’s PMTA Progress Report
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Published February 17th, 2021

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5 Things Your PMTA Needs to Make it to Substantive Review
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Published February 2nd, 2021

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The PACT Act and What it Means for the Electronic Cigarette Industry
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Published January 19th, 2021

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Mask Manufacturing Matters – Benefits of Buying Domestic
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Published January 12th, 2021

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Understanding Vape PMTA Statuses
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Published January 5th, 2021

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Your Vape PMTA & FDA’s New Consumer Research Guidance
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Published December 18th, 2020

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