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2013 Top FDA Warning Letter Findings

For Clinical Investigators, Sponsors and IRBs

As we have done the past several years, IMARC has scoured the 2013 warning letters posted on the FDA’s website to compile the top findings for investigators. This year, we took a look at the top findings for Sponsors and IRBs as well!

If, after an inspection, the FDA determines that serious violations of the federal regulations, particularly those that included human subject protection or data integrity issues, occurred at the site, they may issue a warning letter.

Complete the form to read more about the 2013 Top FDA Warning Letter Findings for Clinical Investigators, Sponsors and IRBs!

2013 Top FDA Warning Letter Findings

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