FDA Communications

10 episodes

The FDA was put into place to ensure that public health remained protected by regulating the manufacturing, distribution and marketing of a wide range of products. This in turn means that it has a very broad mandate to inspect companies to make sure that they are not endangering public health.

Responding to an FDA Inspection – Part 4 (Preparing a War Room)

FDA Communications

Responding to an FDA Inspection – Part 4 (Preparing a War Room)

August 8, 2019Add comment

It is necessary for companies to prepare before an FDA inspection to ensure that they are in compliance. How should you develop a plan...

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Responding to an FDA Inspection – Part 3 (Preparing a War Room)

FDA Communications

Responding to an FDA Inspection – Part 3 (Preparing a War Room)

August 8, 2019Add comment

Companies must develop a plan to ensure that they are in compliance with FDA regulations during inspections. How should they accomplish...

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10 Ways to Communicate With the FDA

FDA Communications

10 Ways to Communicate With the FDA

August 1, 2019Add comment

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FDA Warning Letter: Vivus

FDA Communications

FDA Warning Letter: Vivus

July 11, 2019Add comment

The FDA recently went after VIVUS, a pharmaceutical company, for making false health claims about its product. Inappropriate drug...

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