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...

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...

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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