FDA News Update
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…
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…
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 The Draft Guidance document is available here.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…
Medical Device User Fee Rates for Fiscal Year 2018
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,…
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 FSMA inspections are well underway. The Food Safety Modernization Act (FSMA) is slowly beginning to roll out. The implementation is a learning curve…
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?
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…
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…