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FDA Bitcoin

FDA Bitcoin FDA Bitcoin related questions are cropping up as the cryptocurrency continues to gain steam. This post discusses whether the FDA accepts Bitcoin or whether Bitcoin or blockchain technologies are FDA approved. The first question bound to bubble-up at some point – does the FDA accept Bitcoin? The short answer is, no. The FDA does

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CDER Direct

CDER Direct   CDER Direct is one of two tools commonly used for drug establishment registration, National Drug Code (NDC) relabeler code request, and drug listings. It is intended as an improvement on the Electronic Submissions Gateway (ESG) portal that relies on a SPL X-form editor. The integration of the SPL-X editor into the system is

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FDARA Marketing Status Report

FDARA Marketing Status Report FDARA Marketing Status Report deadline about 4-weeks away. In August 2017, the FDA Reauthorization Act of 2017 (FDARA), was passed and signed into law. FDARA reauthorizes the Prescription Drug User Fee Act (PDUFA) for the fifth time, the Medical Device User Fee Amendments (MDUFA) for the third time, and both the Generic Drug

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FDA Homeopathic Drugs

FDA Homeopathic Drugs FDA Homeopathic Drugs are subject to a new enforcement policy that could lead to big changes. Current homeopathic drugs are the subject of a Compliance Policy Guide (CPG), which is an explanatoryatory note for FDA staff and industry.  As CPG Sec. 400.400 explains, the FDA recognizes and permits homeopathic drugs recognized by

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FDA Cosmetic Safety and Modernization Act (S2003)

FDA Cosmetic Safety and Modernization Act (S2003) Yesterday, October 2, 2018, Senator Orrin Hatch introduced the FDA Cosmetic Safety and Modernization Act (S2003). The proposed bill, like many of its predecessors, including Personal Care Products Safety Act (S.1113) and Cosmetic Modernization Amendments of 2017 bill (H.R. 575), would fundamentally change the cosmetic industry.  Senator Hatch’s FDA Cosmetic Safety

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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 The Draft Guidance document is available here.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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