Letter

Letter to Food and Drug Administration (FDA) on Good Laboratory Practices and Animal Welfare Regulations


01.09.20

Excerpt: “On January 26, 2018, in response to animal deaths in research studies conducted by FDA’s National Center of Toxicological Research, then-FDA Commissioner Scott Gottlieb directed an independent, third-party investigation of FDA’s animal research programs. Over the last several months, Committee staff have been working with FDA to obtain documents that would provide the findings of the third-party investigation. FDA has provided an undated, unattributed summary document entitled, “Securing Animal Welfare across FDA’s research facilities,” and some email responses. However, this document indicated there were underlying audits. Additional documents are needed to ensure that the Committee has all reports and information provided to FDA either directly or derived from the third-party investigation, and to understand fully the circumstances for FDA’s decision to seek an independent, third-party investigation,” write Walden, Pallone, Guthrie, and DeGette in the letter.

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Letter