IRB receives warning letter

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Related tags: Institutional review board

The FDA has issued a warning letter to a Californian IRB for failure to have at least five members and a lack of written procedures.

Institutional review boards (IRB) must be composed of at least five members, none of whom should review if there is a conflict of interest. However, the US Food and Drug Administration found Napoli LLC, collocated with West Coast IVF Clinic, failed to meet these requirements.

In that your sworn, signed affidavit states you conducted a clinical study that was approved by the "local IRB at West Coast IVF Clinic," whose membership consisted of yourself and an embryologist​”, says the warning letter​.

Related topics: Clinical Development

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