FDA warning letter: Lovelace Biomedical Research Institute

FDA issued a warning letter to Robert W. Rubin, CEO of Lovelace Biomedical Research Institute, concerning nonclinical studies of investigational drugs. FDA cites inadequate quality assurance review of final reports, including omissions of animal observations and dosing issues recorded in raw data.

Why it matters: The letter highlights raw data review and complete final study reporting as concerns in nonclinical work supporting drug research.