• Deanna Clark-Esposito

What to Do Now That FDA's PMTA Deadline Has Passed


Acceptance: 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.


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.


Action: 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.  

Source: Information obtained from fda.gov.

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 contact@clarkespositolaw.com, or by completing the Contact form at the bottom of our Home page.


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