Marketing Value Of Abuse-Deterrent Labeling Weighed At Vantrela Review
Executive Summary
Advisory committee members concerned about 'unintended consequences' of labeling opioid products as having deterrent effects want FDA to closely monitor promotion.
You may also be interested in...
Opioid Clinical Efficacy Standards Need Rethinking, FDA Panel Says
Outcomes measures should go beyond self-reported pain scores to include effects on function and quality of life, advisory committee members said during review of Teva's long-acting opioid Vantrela.
When Is An Abuse-Deterrent Claim FDA Approved?
Agency says it is seeing confusion in the marketplace when it comes to distinguishing between agency-approved labeling claims and advertising about products that are intended to be abuse deterrent.
When Is An Abuse-Deterrent Claim FDA Approved?
Agency says it is seeing confusion in the marketplace when it comes to distinguishing between agency-approved labeling claims and advertising about products that are intended to be abuse deterrent.