Comments on the FDA’s Draft Guidance for Industry Entitled “Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework”
Public Citizen finds the draft guidance overall to be woefully inadequate because its cursory content is far more focused on the nonspecific, generalized factors that the Food and Drug Administration (FDA) itself will consider when reviewing a new drug application (NDA) for an opioid, rather than providing industry with guidance as to what specific benefit and risk information should be sought out and included in future NDAs for new opioids.
See Public Citizen’s other work on opioid drug issues.