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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 | By

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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