Posts by Marc Sanchez
FDA Bitcoin
FDA Bitcoin related questions are cropping up as the cryptocurrency continues to gain steam. This post discusses whether the FDA accepts Bitcoin or whether Bitcoin or blockchain technologies are FDA approved. The first question bound to bubble-up at some point – does the FDA accept Bitcoin? The short answer is, no. The FDA does not accept…
Read MoreCDER 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 as an improvement on the Electronic Submissions Gateway (ESG) portal that relies on a SPL X-form editor. The integration of the SPL-X editor into the system is one of its…
Read MoreFDARA 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 Prescription Drug User Fee Act (PDUFA) for the fifth time, the Medical Device User Fee Amendments (MDUFA) for the third time, and both the Generic Drug User Fee Amendments (GDUFA)…
Read MoreFDA 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 Policy Guide (CPG), which is an explanatoryatory note for FDA staff and industry. As CPG Sec. 400.400 explains, the FDA recognizes and permits homeopathic drugs recognized by a Homeopathic Pharmacopeia.…
Read MoreFDA 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 Care Products Safety Act (S.1113) and Cosmetic Modernization Amendments of 2017 bill (H.R. 575), would fundamentally change the cosmetic industry. Senator Hatch’s FDA Cosmetic Safety and Modernization Act (S2003) includes familiar changes like…
Read MoreFDA 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 The Draft Guidance document is available here.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 and here. Only a summary of the microneedling guidance posted today. Below is the constituent update announcing the release. As expected it appears the FDA will propose a two pronged approach…
Read MoreMedical 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 2018 will impact the annual registration fee along with a number of submissions. For FY18, the registration fee for each establishment is $4,631 (in U.S. Dollars). All establishments that are…
Read MoreRegulatory 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, a regulatory mediator can help parties reach a resolution without spending valuable time educating a mediator about the regulations. Common regulatory disputes involve Lanham Act for unfair trade practices, trademark…
Read MoreInterview 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” /><param name=”wmode” value=”transparent” /><param name=”menu” value=”false” /><param name=”allowScriptAccess” value=”always” /><embed src=”http://www.blogtalkradio.com/btrplayer.swf” flashvars=”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&shuffle=false&callback=http://www.blogtalkradio.com/FlashPlayerCallback.aspx&width=210&height=105&volume=80&corner=rounded” width=”210″ height=”105″ type=”application/x-shockwave-flash” pluginspage=”http://www.macromedia.com/go/getflashplayer” quality=”high” wmode=”transparent” menu=”false” name=”214821″ id=”214821″ allowScriptAccess=”always”></embed></object><div style=”font-size: 10px;text-align: center; width:220px;”> Listen to <a href=”http://www.blogtalkradio.com”>internet…
Read MoreFDA Textbook by Springer International; Release Date Annouced
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 industry and the FDA. Still there have been dozens of inspections. FDA Atty completed a Freedom of Information Act (FOIA) request with the FDA’s Center for Food Safety and Nutrition…
Read MoreWhat 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 (DOJ) trial attorney to file a complaint in Federal District Court. This type of filing requires a response otherwise a default judgment will be entered against the defendant facility. In…
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