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When Biden took office, the PMTA and Se principles promulgated by FDA were frozen?

2021/02/20|Industry news

On January 19, 2021, according to a news circular issued by the U.S. Food and drug administration, the agency has set two key principles for companies seeking to be able to market new tobacco products.

According to the introduction, both of the two principles include the content, format and minimum requirements for review of tobacco pre marketing application (PMTA) and substantial equivalence (SE) reports. PMTA and Se are two ways that manufacturers can choose when they need to apply to FDA for new tobacco product marketing license.

However, recently, according to the news from the US tobacco network, with the new US President Biden taking office, all regulations issued by the former president trump administration have been temporarily suspended, including the provisions of the US Food and Drug Administration on the pre marketing application (PMTA) for new tobacco products.

According to reports, all regulations that have not yet come into effect during the trump administration have been temporarily suspended by the White House Office of management and budget. This means that the FDA's previous provisions on the application for new tobacco products before marketing (PMTA) and the principle of substantial equivalence (SE) will also be suspended.

After Biden took office, all new regulations proposed by trump will be frozen, and the thawing time will depend on the situation, until Biden's government confirms which regulations can be allowed. Although the application for new tobacco products (PMTA) and the principle of substantial equivalence (SE) have been temporarily frozen, the implementation time can not be determined, but it is only a matter of time.

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