FDA Q&A

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…

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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”…

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FDA Textbook by Springer International; Release Date Annouced

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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…

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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…

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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…

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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…

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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…

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FDA New Tobacco Deadlines

As is well known by now the FDA Deeming Regulation is effective as of August 8, 2016. What is less well understood are the various…

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FDA E-Cigarette Rule Finalized

The FDA e-cigaratte rule finalized. That is the breaking update from the FDA on Thursday May, 5 2016. The new rule known as the “deeming”…

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FDA Tanning Bed Rule

The FDA is issuing a new tanning bed rule. The FDA tanning bed rule is actually a set of two proposed rules simultaneously released on…

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FDA Exemption to E-Cigarette Deeming Rule

***UPDATE December 16, 2016*** The draft text of the Omnibus Bill does not include the FDA exemption to e-cigarette deeming rule. If this is confirmed,…

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