FDA News Update
What represents an FDA Consent Decree?
An FDA Consent Decree represents a serious step in FDA enforcement. To obtain a consent decree the FDA must work with the Department of Justice…
Is Vape Doomed?
As state bans begin to join major city bans and the FDA announcement of a new crackdown the question many people are asking is vape…
Emerging Growth Companies
Our firm offers works with companies of all sizes and at all different stages of growth. Emerging growth companies in regulated industry can need special…
Private: Technology and Privacy
As the number of devices that connect to the Internet increases and audio and video content offerings grow, understanding issues unique to digital media and…
SNAP Trafficking Charge Letter
Overview of USDA/FNS Charge Letter Response and Appeal SNAP Trafficking charge letter act as the official notification from the USDA FNS (United States Department of…
See the Exemptions to the Proposed Rule for Preventative Controls for Animal Food
The charts below do not contain all of the information necessary to determine the proposed requirements for compliance in a particular circumstance. Consult the proposed…
FDA Form 483 Response Strategy – FY 2012 Inspectional Observation Summaries
FY 2012 Inspectional Observation Summaries FDA Form 483 response strategy – perhaps the best strategy to both prepare for a
Electronic and Radiological Devices Accession Numbers
Electronic and radiological device accession numbers are one of several parts of bring a radiation emitting product to market. Accession numbers refer to the unique FDA identifiers for…
Tobacco Health Certificate (NCTTP)
The tobacco health certificate will be one of two submissions for newly regulated tobacco companies (vape, e-cig, e-liquid, cigar, hookah, etc.). These certificates must be…
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…