FDA Looks to Raise Quality Standards for Nonclinical Studies of Product Submissions

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

The proposed rule, published Aug. 24, would amend good laboratory practices for nonclinical studies to require facilities to undertake a comprehensive quality system approach to oversee these studies.

Nonclinical trials are conducted under laboratory conditions to evaluate the safety and toxicity of products and 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.  — José Vasquez