FDA Approval
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 and impact every…
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 states advertising and packaging warnings…
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…
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…
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…
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 as the “deeming”…
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…
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…
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 deeming rule. If this is confirmed,…
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…
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…