FDA EIR - Daniel P. Petrylak, M.D. - September 20, 2019

An FDA routine inspection of clinical investigator Daniel P. Petrylak, M.D., located in New Haven, CT, was conducted from September 16 to September 20, 2019. The inspection, requested by the Center for Drug Evaluation and Research (CDER), aimed to assess compliance with applicable regulations for clinical investigations under the Clinical Investigators and Sponsor Investigator Compliance Program Guidance Manual. Specifically, the inspection reviewed Protocol SGN-E7019, a clinical trial for enfortumab vedotin sponsored by Seattle Genetics, Inc. and Astellas Pharma Global Development, Inc., in support of a Biologics License Application. During the inspection, no formal Form FDA-483 (Inspectional Observations) was issued. However, two discussion items were noted. First, it was observed that some study subjects did not complete their health questionnaires, with no corresponding documentation to explain the omissions in the source records. Second, Dr. Petrylak's signature was missing from the Site Initiation Visit Training Log, despite being queried by a monitor. While he did not retrospectively sign the log, he provided an attestation on September 18, 2019, confirming his participation in the training. Dr. Petrylak confirmed he would take these observations into consideration to enhance their clinical trial practices. The inspection concluded without the collection of samples or any refusals encountered.