After the September 9 FDA PMTA Filing Deadline
Following Pre-Market Tobacco Application filing, there are a set of phases which FDA and the Center for Tobacco Products will follow in reviewing, accepting or rejecting an application, and ultimately issuing or declining a marketing order. These phases proceed in the following order:
During this administrative review, FDA will ensure your product falls under Center for Tobacco Products jurisdiction and confirms that the statutory and regulatory requirements of an application are met. This phase may result in either a Refuse to File (RTF) letter or a filing letter.
2 Filing and Substantive Review:
A preliminary scientific review is performed to ensure all required items are present. This is followed by a substantive review of scientific evidence provided in the application. From here, the application may either proceed, or additional information will be requested via a deficiency letter or an environmental information request letter.
At this final stage, following review of the entire PMTA, the applicant may receive either a marketing order letter or a no marketing order letter.
Do you have questions about any protocols you should implement now that the deadline has passed? Do you have other questions about the PMTA process?
If so, please contact Clark-Esposito Law Firm, P.C. at email@example.com, or by clicking below and completing the Contact form at the bottom of our Home page.
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Information about the review process of PMTAs was obtained from fda.gov.