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Read the blog for important updates to FDA and USDA rules and regulations that could affect your business.

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CDER Direct

CDER Direct   CDER Direct is one of two tools commonly used for drug establishment registration, National Drug Code (NDC) relabeler code request, and drug listings….

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FDARA Marketing Status Report

FDARA Marketing Status Report FDARA Marketing Status Report deadline about 4-weeks away. In August 2017, the FDA Reauthorization Act of 2017 (FDARA), was passed and signed…

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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…

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FDA Cosmetic Safety and Modernization Act (S2003)

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,…

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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 The Draft Guidance document is available here.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…

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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,…

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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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FDA Consent Decree

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…

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FDA Amazon 2017

FDA Amazon 2017 FDA Amazon 2017

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