Development of Non-Opioid Analgesics for Acute Pain; Draft Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Development of Non-Opioid Analgesics for Acute Pain." In connection with the SUPPORT for Patients and Communities Act (SUPPORT Act), the purpose of this guidance is to spur the development of alternatives to opioids for the management of acute pain by providing information about product development-related issues, "opioid-sparing" claims, and expedited programs as they pertain to this purpose.