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Category: FDA

AAP V FDA RULING

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| FDA

Download Legislation Here Court ruling of AAP V. FDA was released today regarding PMTA. Court Order: The FDA shall require that, for new tobacco products on the market as of the August 8, 2016 effective date of the Deeming Rule (“New Products”), applications for marketing order must be filed within 10 months of the date […]

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FDA June Updates

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| FDA

As third quarter is officially in full swing now is a great time to breathe and reflect on what actually happened in second quarter especially in June. The FDA as we all know was very busy in the month of June, but while PMTA has dominated the news in the industry; here are some updates […]

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PMTA Guidance Update

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| FDA

The FDA has officially put out new guidance for the PMTA also known as Premarket Tobacco Product Applications. The official statement the FDA issued with the announcement of these new guidelines was “The FDA is committed to providing a solid, science-based regulatory foundation to ensure that ENDS products authorized for marketing are appropriate for the […]

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FDA Invites Eliquid Manufacturers to Schedule Site Tour

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| FDA

As of May 23, 2019 the FDA is starting a new program “to give CTP staff an opportunity to visit facilities that develop, manufacture, or test ENDS devices or e-liquids… to gain a better understanding of the processes involved in the development, manufacturing, and testing of ENDS devices and e-liquids.” The department in charge of […]

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