Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies

The good laboratory practice (GLP) regulations are intended to assure the quality and integrity of the safety data submitted to FDA in support of the approval of regulated products. The required information will help assure that only safe products are approved for marketing. Respondents to the collection are those submitting applications to FDA for research or marketing permits.

The latest form for Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies expires 2027-01-31 and can be found here.