FDA News Update
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 The Draft Guidance document is available here.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…
Medical Device User Fee Rates for Fiscal Year 2018
The US FDA announced Medical Device User Fee Rates for Fiscal Year 2018 on Monday morning (August 28, 2017). The Medical Device User Fee Rates for Fiscal Year…
Interview on AME Food Testing Show
My Interview on Whether FSMA will Require Food Producers to Test their Products <object classid=”clsid:D27CDB6E-AE6D-11cf-96B8-444553540000″ codebase=’http://download.adobe.com/pub/shockwave/cabs/flash/swflash.cab#version=9,0,0,0′ width=’210′ height=’105′ name=”214821″ id=”214821″><param name=”movie” value=”http://www.blogtalkradio.com/btrplayer.swf?file=http%3A%2F%2Fwww.blogtalkradio.com%2Fame-foodtestingshow%2F2011%2F11%2F09%2Fwill-fsma-require-food-producers-to-test-their-products%2Fplaylist.xml&autostart=false&bufferlength=5&volume=80&corner=rounded&callback=http://www.blogtalkradio.com/flashplayercallback.aspx” /><param name=”quality” value=”high”…
FSMA Inspections
FSMA inspections are well underway. The Food Safety Modernization Act (FSMA) is slowly beginning to roll out. The implementation is a learning curve both for…
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…