FDA CRL - ResQ Pharma

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter for ResQ Pharma's New Drug Application (NDA 217382) for Nutrilipid 20% soybean oil emulsion for intravenous infusion. The FDA determined the application could not be approved in its current form due to significant deficiencies in Clinical and Biopharmaceutics and Human Factors. A primary issue centered on the company's reliance on published literature, primarily involving Intralipid 20%, to support the use of Nutrilipid 20% for local anesthetic systemic toxicity (LAST). The FDA found the scientific bridge between the two products inadequate, noting differences in inactive ingredients and statistically significant physicochemical properties. The application lacked sufficient justification for these differences not affecting in vivo performance and did not provide data on comparable drug capture capability. Furthermore, details on the literature search strategy were deemed insufficient. Regarding Human Factors, the FDA noted several use errors and difficulties with critical tasks in the proposed device's validation study. These issues, stemming from high cognitive load, confusion with dose calculations, and unfamiliarity with emergency procedures, indicated the user interface does not support safe and effective use, raising concerns about medication errors. To address these deficiencies, ResQ Pharma must provide additional data demonstrating comparable drug capture capability, justify the impact of physicochemical differences, and submit detailed literature search methods. For human factors, the company needs to develop and implement additional risk controls, including device design modifications and labeling changes, to ensure safe and effective use.