PMTA Process
U.S. Premarket Tobacco Product Applications (PMTA)
All tobacco products originally covered by the Family Smoking Tobacco Control Act are required to undergo premarket review, unless they are “grandfathered products.” Following the 2016 deeming rule, all newly deemed tobacco products became subject to premarket review requirements as well.
Let Us Guide You Through the Process
Our ultimate goal is to positively impact the lives of cigarette smokers by leveraging our expertise to help purpose-driven companies achieve regulatory success in the tobacco industry.
We specialize in PMTA strategy development, preparation, submission and post-market reporting. Without the right partner, regulatory compliance can become an overwhelming and expensive endeavor.
McKinney Regulatory Science Advisors, LLC recasts the challenge of regulatory compliance into business opportunities.
Navigating rapid industry shifts requires trustworthy advisors
who have YOUR best interests in mind.
How to Prepare a PTMA
A Premarket Tobacco Product Application (PMTA) is an application submitted by any person for any new tobacco product seeking an FDA marketing order under section 910(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act.
Our Approach
Regulatory
Assessment
We conduct an assessment of your current approach to design, manufacture and market your new tobacco product.
Regulatory Strategy
Development
We partner with your company to develop a regulatory strategy that is unique and specific to your business needs.
Product
Testing
Our subject matter experts execute scientific studies and generate data that is necessary to responsibly market your new product.
Application
Preparation and Filing
We will develop and manage timelines, guide and direct writing, and oversee the review, publishing and submission of your PMTA to ensure your application satisfies FDA requirements.
Post-Submission
Requirements
We will leverage our experience and advise you on the best approaches to successfully complete the post-submission process.
Post-market
Requirements
We offer expert guidance and proficiently manage the post-marketing reporting obligations required to maintain market authorization for your products.
Contact Us
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