FDA Seeks to Raise Standards for Nonclinical Studies to Ensure Data Integrity

The FDA is proposing that nonclinical studies intended to support submissions to the agency meet higher quality management standards.

The proposed rule, to be published Wednesday, would amend good laboratory practices for nonclinical studies to require facilities to undertake a comprehensive quality system approach—known as a GLP Quality System—to oversee these studies.

Nonclinical trials comprise in vivo and in vitro experiments conducted under laboratory conditions to evaluate the safety and toxicity of products. These studies serve as a precursor to initial human studies.

The proposed rule takes into account current practices as well, such as multisite studies, offering industry flexibility in meeting the proposed standards.