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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. It is intended…
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 into law. FDARA reauthorizes the…
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 of a Compliance…
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 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 The Draft Guidance document is available here.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…
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 compliance questions,…
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…