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.

Feature image for podcast episode 224

FDA Communications

How the FDA Conducts a Clinical Trial Inspection: An Interview With Former FDA Inspector Patrick Stone

November 12, 2020Add comment

Clinical studies have become increasingly virtual because of COVID-19. How has this affected the way the FDA inspects clinical trials? Join...

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FDA Communications

Responding to an FDA Inspection: What Can the FDA Do

September 3, 2019Add comment

How can you ensure readiness and compliance for FDA inspections? It is important for companies to investigate who the FDA targets, and how...

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FDA Communications

Responding to an FDA Inspection: Preparing a War Room

September 3, 2019Add comment

Companies must develop a plan to ensure that they are in compliance during inspections to ensure FDA readiness

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stacked envelopes

FDA Communications

How to Communicate Effectively with the FDA

August 27, 2019Add comment

Opening up lines of communication with the FDA can often be intimidating for companies, and the process does not seem straightforward...

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Responding to an FDA Inspection – Part 1 (FDA Findings, What the FDA Can Do)

FDA Communications

Responding to an FDA Inspection – Part 1 (FDA Findings, What the FDA Can Do)

August 8, 2019Add comment

How should your company prepare for FDA inspections? In this episode, FDA regulatory attorney Darshan Kulkarni discusses the steps...

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Responding to an FDA Inspection – Part 2 (FDA Findings, What the FDA Can Do)

FDA Communications

Responding to an FDA Inspection – Part 2 (FDA Findings, What the FDA Can Do)

August 8, 2019Add comment

How can you ensure readiness and compliance for FDA inspections? Join FDA regulatory attorney Darshan Kulkarni as he talks about how to...

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