FDA Approval

FDA Vaping

FDA Vaping The FDA vaping regulation (a/k/a Deeming Regulation) currently requires companies to register and list their products. Previous posts discussed the FDA vaping regulation…

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FDA New Tobacco

FDA New Tobacco FDA new tobacco regulation also known as the Deeming Regulation takes effect in 30-days (August 8, 2016). The regulations are broad, complex…

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FDA Comments Deeming Regulation

FDA Comments Deeming Regulation This afternoon I attended a meeting with CTP Director Mitch Zeller regarding the deeming regulation (“FDA Comments on Deeming Regulation”). CTP Director…

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Tobacco Products Required Warnings

Tobacco Products Required Warnings Among the key requirements of the FDA’s new Deeming Tobacco rule are that tobacco products bear the required warnings. This rule…

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FDA Device Meetings

FDA Device Meetings Any meeting with the FDA on it’s White Oak campus can be intimidating, but a FDA device meeting to assess both pre-market…

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E-Cig Rule Practical Guide

FDA E-Cig Rule Practical Guide Now that the shock of the new FDA E-Cig rule (Deeming Rule) is settling in it is time to get…

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Vaporizers, E-Cigarettes, and other Electronic Nicotine Delivery Systems (ENDS)

FDA ENDS The FDA deeming rule extended authority over Vaporizers, E-Cigarettes, and other Electronic Nicotine Delivery Systems (ENDS). There are several key requirements that will go…

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FDA E-Cigarette Rule Finalized

FDA E-Cigarette Rule Finalized The FDA e-cigaratte rule finalized. That is the breaking update from the FDA on Thursday May, 5 2016. The new rule known…

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FDA Microneedling Presentation

FDA Microneedling This past month I joined the American Society for Aesthetic Plastic Surgery (ASAPS) for their annual conference. This year the ASAPS conference was held…

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Amazon Registration Certificates and Seller Support

Amazon Registration Certificate A recent post on Amazon Registration Certificates generated a number of questions along with shared frustrations. In the previous post I talked…

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FDA Exemption to E-Cigarette Deeming Rule

FDA Exemption to E-Cigarette Deeming Rule ***UPDATE December 16, 2016*** The draft text of the Omnibus Bill does not include the FDA exemption to e-cigarette…

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FDA Picamilon Status

FDA Picamilon Status In the FDA’s most recent set of warning letters Picamilon noticeably stood out with five (5) firms receiving a FDA Warning Letter…

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