FDA Q&A

Marijuana, THC, and the US FDA – What Does Increasing Legalization Mean for Food, Drugs, and Dietary Supplements?

Colorado made headlines this past week when its decriminalization of marijuana went into effect. Since that time an increasing number of calls and e-mails rushed…

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Trans Fat Banned Under New FDA Rule

The US Food and Drug Administration announced today it will take steps to curb the use of partially hydrogenated oils from processed foods. The Agency…

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FDA/USDA Shutdown Ending, Expect Lengthy Delays

The government shutdown that shuttered the doors of the USDA and FDA has ended. The Agencies are expected to return back to normal operations on…

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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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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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Proposed Foreign Supplier Verification Rule under FSMA Released by FDA

The US Food and Drug Administration issued the long delayed and much anticipated Foreign Supplier Verification Rule under the Food Safety Modernization Act (FSMA) today….

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Webinar Providing FSMA Update on Produce Safety and Preventative Controls Rule

Looking to learn the latest on the Food Safety Modernization Act (FSMA)?

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Slides from FX Conferences – FSMA Produce Safety Rule

Looking to learn more about the produce safety rule? Download my slide deck from FX Conferences (click

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IRS Issues Regulations on $20 billion Medical Device Tax

Proposed regulations

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FDA and Industry Reach Agreement in Principle on Medical Device User Fees (MDUFMA)

The FDA

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