Enforcement

12
Jul

Understanding the Mutual Recognition Agreement (MRA)

It certainly seems that the world is getting smaller and this concept has been coming to the regulated industry for quite some time now.  As early as 1999, the European Commission has been working diligently with the EMA and other regulatory bodies throughout the world to form Mutual Recognition Agreements (MRAs) related to inspections and […]

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23
May

FDA’s Website Re-Design – Did Something Get Left Behind?

For those of us in the regulated industry, we rely on FDA’s website for many different things. FDA.gov has historically been not the most intuitive website, with all of the Centers running their own pages, and inconsistencies occurring as a result of having many “chefs in the kitchen”, as the saying goes. On April 26, […]

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11
Feb

Gottlieb Opens the Toolbox for Dietary Supplements – Beware the Hammer!

In our blog, over the years, we have addressed the issue of dietary supplements and some actions of bad actors relative to the chase for the almighty dollar.  Today, Commissioner Gottlieb announced the “agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight” (here) . The Dietary Supplement Health and […]

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