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 The Draft Guidance document is available here.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…

Read More

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…

Read More

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”…

Read More

FDA Textbook by Springer International; Release Date Annouced

Read More

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…

Read More

FDA Amazon 2017

FDA Amazon 2017

Read More

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…

Read More

VET Permit Gelatin

Read More

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…

Read More

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…

Read More

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…

Read More

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…

Read More