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Regulatory Focus™ > News Articles > RA Manager: An Insider’s Look at Device Research Warning Letters

RA Manager: An Insider’s Look at Device Research Warning Letters

Posted 01 October 2008

If you have been involved in any aspect of clinical research, you are all too aware of the compliance tool most frequently employed by the US Food and Drug Administration (FDA): the Warning Letter (WL). Recipients generally view Warning Letters in a negative light since they point out significant departures from the regulations rather than conformance to them. However, well-informed individuals know that these letters can also be used to gain valuable insights from the agency and to improve systemic research activities.

 

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