FDAnews Drug Daily Bulletin

Drugmakers, PhRMA, BIO Push Back Against FDA Proposal for Nonclinical GLPs

Feb. 2, 2017

Several large drugmakers and industry groups commented on FDA’s proposal to require higher quality management standards for nonclinical studies used to support product applications.

The new rule, first proposed in August, would establish a GLP quality system requiring additional management roles and written procedures for how to conduct tests, archive records, and other activities typically omitted from study protocols. Several commenters said this could create confusion over who is ultimately responsible for a study.

The FDA said the onus to comply with the standards would fall on upper management. It would cover both in vivo and in vitro experiments. The proposed rule received 175 comments.

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