Print Edition - FDA Drug Enforcement: An Analysis of Warning Letter Trends

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April 2012
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What are the five hottest areas of concern showing up in FDA warning letters?

How are the agency’s changing priorities impacting its enforcement trends?

And what can you do to avoid common pitfalls cited in the FDA’s most recent Warning Letters?

The answers are no mystery. They appear in this standout management report from FDAnews.

This report is must reading for drug and biologics makers ... clinical trial sponsors and sites ... clinical laboratories ... government regulators ... lawyers and consultants ... everyone whose livelihood is affected by FDA drug inspections.

This management report couldn’t come along at a better moment. The FDA has gotten tough in a variety of uncomfortable new ways, such as:

  • More frequent drug company inspections, by better-trained and sharper-eyed examiners
  • Executive accountability, a new focus of warning letters
  • Greater scrutiny of supplier quality, clinical investigator compliance and internet marketing
  • And a doubling of drug company inspections compared to past years.

FDA Drug Enforcement dives deep into the substance of warning letters, teasing out trends buried in swamps of bureaucrat-speak. Did you know:

  • GMP inspections: FDA enforcement remains focused on inadequate efforts to investigate failures. Weak SOPs are another frequent finding. Outsourcing to unqualified vendors emerged as an issue for two companies. The agency also continues to stay focused on international drugmakers; 30 percent of drugmaker inspections now are taking place outside the United States.
  • Clinical trials: The agency has shifted its focus away from IRBs, redirecting efforts to clinical sites. There’s a new emphasis on protocol adherence, drug accountability, informed consent, clinical records and adverse events compliance.
  • Marketing drug products: The action has moved to the internet. The majority of warning letters dealing with marketing of products now focus on internet activities.

And these findings are the tip of the iceberg.

One warning letter ... one disciplinary action that puts you in a bad light with the FDA and your customers ... is one too many. Why risk it when FDAnews does the hard work for you, analyzing and explaining the agency’s likely upcoming moves. Don’t allow your next examination to go off the rails.

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