Lovelace Biomedical Research Institute
1 extracted findings
FDA source excerpt, selected passage
Failure of the quality assurance unit (QAU) to review the final study report to [en]sure that the reported results accurately reflect the raw data of the nonclinical laboratory study [21 CFR 58.35(b)(6)].
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
01
Failure of the quality assurance unit (QAU) to review the final study report to [en]sure that the reported results accurately reflect the raw data of the nonclinical laboratory study [21 CFR 58.35(b)(6)].
Source passage selected by the model
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.
21 CFR 5821 CFR 58.35(b)(6)