Answer: Proposed Section 170.101(c) requires that all nonclinical laboratory studies be performed under good laboratory practices(GLPs). This provision applies to toxicology or biologically related studies that are indicated under Part 58 of the Food Additive Regulations, "Good laboratory practice for nonclinical laboratory studies." Under Part 58, the studies requiring such GLP attention are identified as in vivo or in vitro studies, but not studies to determine physical or chemical characteristics, i.e., not migration studies.
Proposed Section 170.101(c)(3) requires that any data from a toxicity study conducted after 1978, but not conducted in compliance with GLPs in accord with Part 58, must be validated by an independent third party prior to submission to FDA. This latter provision was not required by FDA in the petition process.
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