Opioid Continuing Education Rules Hamper REMS Assessments
This article was originally published in The Pink Sheet Daily
Executive Summary
Sponsors do not have access to list of who completed the courses, so they can't tell if those prescribers changed their behavior.
You may also be interested in...
FDA's Opioid REMS Review Puts Brakes On Mandatory Education Push
Requiring training and certification for extended-release opioids would involve at least 320,000 prescribers and impact 21 million outpatient prescriptions, reviewers note in a briefing memo that is more skeptical of the mandatory approach than FDA's leadership has been.
US FDA Gene Therapy Accelerated Approval Guidance Will Describe ‘Buckets’ Of Use Scenarios
Forthcoming guidance is expected to describe areas of “low-hanging fruit” and those that are more challenging for use of the expedited pathway, Center for Biologics Evaluation and Research Director Peter Marks said.
Puberty Blockers: FDA's Califf Asked If REMS, Boxed Warning Against Off-Label Use In The Works
FDA Commissioner Robert Califf tells House appropriations subcommittee chair the agency will 'consider any information that may be available' on off-label use of puberty blockers for gender dysphoria before making a regulatory decision.