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Heated tobacco regulatory reports

Regulatory report: Q&A – US FDA final guidance on PMTAs and SE reports

Written by || 4th November 2021 || Heated tobacco regulatory reports , Nicotine pouches regulatory reports , Regulatory reports | Regulation and legislation | GeographiesNorth America United States

On 4th October 2021 the US Food and Drug Administration (FDA) issued two final rules providing additional information on the requirements for Premarket Tobacco Product Applications (PMTAs) and Substantial Equivalence (SE) reports. This report aims to answer questions that may be raised on this topic, in particular taking into account the public comments and responses the FDA has offered.

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Regulatory report: Q&A – US FDA final guidance on PMTAs and SE reports

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Berta Camps Bisbal

Senior legal analyst
Berta has a law degree from the University of Barcelona and a Juris Doctor degree from Nova Southeastern University (Florida). She has worked as a faculty assistant in legal research in Florida, was a member of the Law Review, and has interned for a magistrate judge of the US District Court for the Southern District of Florida. Berta focuses on US legal analysis, including tracking all federal, state and local regulation. She runs our US interactive regulatory tracker product, following changing regulation on e-cigarettes in all 50 US states.

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