FDA Comment Deadline: Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework

Tuesday, August 20, 2019 - 5:00pm

The Food and Drug Administation (FDA) seeks public comment on its draft guidance for industry titled "Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework." The purpose of this guidance is to describe the benefit-risk framework the Agency uses in evaluating applications for opioid analgesic drugs. This guidance summarizes the information that should be included in a new drug application (NDA) for an opioid analgesic drug to facilitate the Agency's benefit-risk assessment.

Members of the public may submit comments online at Regulations.gov, or via mail. More information is available at this Federal Register notice.