DRUG

Shutdown Delays Medical Device Approvals (510(k)s)

As the shutdown continues the impact continues to be felt.

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Government Shutdown; Update on Impact on USDA & FDA

The US federal government is shutdown. The impact will be felt by all areas of FDA and USDA regulated industry. The FDA will cease all…

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Rare Recall Arrest: Jensen Farms Cantaloupe Owners Arrested, Charged

A rare and stunning arrest was made this week by the FDA and the US Attorney’s Office. Eric and Ryan Jensen, the owners of the…

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Review of FSVP Part 2: The Basic Mechanics of a FSVP

Food Court continues its series discussing the new Foreign Supplier Verification Program (FSVP) rule issued by the US FDA under the Food Safety Modernization Act…

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Review of Proposed Rule for Foreign Supplier Verification Program Review: Part 1 – The Aim and Purpose of Animating the Rule

The US Food and Drug Administration announced the long-awaited Foreign Supplier Verification Rule (FSVP) under the Food Safety Modernization Act (FSMA) on Friday (see our…

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