WASHINGTON, Sept. 11 -- Food and Drug Administration has issued a notice called: Development of Non-Opioid Analgesics for Chronic Pain, Draft Guidance for Industry; Availability.
The notice was published in the Federal Register on Sept. 11 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Development of Non-Opioid Analgesics for Chronic Pain." This guidance is intended to assist sponsors in the development of non-opioid analgesics for the treatment of chronic pain. It describes FDA's current recommendations regarding phase 3 trials for prescription non-opioid analgesi...