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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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FDA FSVP

FDA FSVP FDA FSVP and FSMA Enforcement Update Marc recently attended the Food and Drug Law Annual conference as a speaker alongside FDA’s interim director…

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Microneedling Classification Order

Microneedling Classification Order The FDA issued a Microneedling Classification Order that will fundamentally reshape how microneedling devices are sold and used. The classification order (link here) was…

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Government Shutdown

Government Shutdown A government shutdown now seems increasingly likely (see, Reuters latest headline). This blog wrote extensively on the 2013 Government shutdown (here, here, and…

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FDA Warning Letters 2017

FDA Warning Letters 2017 FDA Warning Letters 2017 is a post summarizing last year’s Warning Letters. Each year the FDA releases an enforcement report along…

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FDA Bitcoin

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…

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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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