FDA

Criminal Charges USPlabs LLC

Criminal Charges USPlabs LLC Breaking News – Criminal Charges USPlabs LLC  The US Department of Justice and the Food and Drug Administration announced criminal charges and…

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FDA Holiday Imports

FDA Holiday Imports The time is fast approaching where US shoppers will begin their holiday shopping. FDA holiday imports are a common feature of the…

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New FDA Automatic Destruction Rule

New FDA Automatic Destruction Rule Under New Authority Re-Export Option May be Removed An ominous sounding new rule goes into effect tomorrow (October 15, 2015)….

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FDA Shutdown – Preparing for the Likely Government Shutdown

***UPDATE: Congress approved a short term budget deal that will fund the government through December 11th. There remains a liklihood that a FDA shutdown could…

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FDA Warning for Kim Kardashian

FDA Warning for Kim Kardashian A Lesson in paid and un-paid user testimonials It is a bit of a surprise to write about Kim Kardashian…

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Regulatory Planning for FDA FY 2016

Regulatory Planning for FDA FY 2016 The FDA operates on a Federal Fiscal Year rather than a calendar year. The FY runs from October 1…

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FDA SEC Reporting – Regulatory Reviews for SEC Forms

FDA SEC Reporting Regulatory Reviews in Form 8-K FDA SEC Reporting does not readily come to mind when considering foods, dietary supplements, drugs, cosmetics (so…

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FDA Label Review – Overview and Tips

FDA Label

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FDA Regulation of Homeopathic Drugs – Meeting Foreshadows Changes

FDA Regulation of Homeopathic Drugs Current Regulation of Homeopathy The FDA currently regulates homeopathic drugs under a 1988 Policy Guide. The Policy Guide is detailed…

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Nutrient Content Claims + KIND Warning Letter

Nutrient Content Claims + Kind Warning Letter What is a Nutrient Content Claim? The US Food and Drug Administration appears to have riled fans of…

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New FDA Expedited Access Pathway Program

New FDA

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FDA Warning Letters

FDA Warning Letters The Significance of Warning Letters FDA Waring Letters are the most commonly used enforcement tool. Employed across product categories FDA Warning Letters…

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