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FDA Microneedling Guidance

FDA Microneedling Guidance FDA microneedling guidance at long last arrived today (Sept. 14, 2018). The Draft Guidance document is available here. Previous posts on microneedling can be found here and here. Only a summary of the microneedling guidance posted today. Below is the constituent update announcing the release. As expected it appears the FDA will propose a

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Regulatory Mediator

Regulatory Mediator Mediation is an increasingly used tool both by courts and parties to avoid litigation. When a dispute involves regulatory issues, such as FDA compliance questions, a regulatory mediator can help parties reach a resolution without spending valuable time educating a mediator about the regulations. Common regulatory disputes involve Lanham Act for unfair trade

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Tobacco Health Certificate

Tobacco Health Certificate A tobacco health certificate will be one of two submissions for newly regulated tobacco companies (vape, e-cig, e-liquid, cigar, hookah, etc.). The certificates must be submitted using the FDA’s Electronic Submission Gateway (ESG). The health certificates are due on one of two deadlines depending on the scale of operations. Those are February

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Drug Establishment Registration

Drug Establishment Registration Drug establishment registration is one of three steps in the FDA Drug Registration process. It is an important step for importers and domestic manufacturers, labelers, and private labelers alike. Drug establishment registration may be one of the first barriers encountered to selling with retailers like Amazon, Walmart, Walgreens or creating Google AdWords

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Walmart VTA Supplier Requirements

Walmart VTA Supplier Requirements Selling with a major retailer is a dream for many companies. When selling with any major retailer it is important to understand the retailer’s regulatory requirements. Walmart VTA supplier requirements (vendor tagged advertisement) is one example. This process is sued by Walmart to approve or reject any radio or TV advertisements

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Amazon FDA Registration Proof

Amazon FDA Registration Proof Amazon FDA registration proof can be a moving target. Is it a certificate, a screen shot, something else!? The answer varies from week to week and from seller support agent to seller support agent. Amazon FDA registration proof is something this blog has tackled on numerous occasions. Over the past six

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FDA New Tobacco Deadlines

As is well known by now the FDA Deeming Regulation is effective as of August 8, 2016. What is less well understood are the various new tobacco deadlines from the regulation. As a reminder the new tobacco deadlines apply to any new tobacco product (electronic nicotine delivery systems (such as e-cigarettes and vape pens), all

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FDA Registration

FDA Registration As September begins it is time to forget about summer and start to focus on FDA registration. This is due to the way the FDA structures its Fiscal Year. The Agency operates on a Fiscal Year that begins October 1 and ends September 30. Any registrations or filing fess paid in one fiscal

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