Should Opioids Be Used Solely For Severe Pain? FDA Seeks Expert Advice
This article was originally published in The Pink Sheet Daily
Executive Summary
The agency is holding a public meeting in February to obtain information on opioid treatment for chronic pain; FDA seeks data to assess whether to restrict use and establish a maximum daily dose.
You may also be interested in...
Citizen Petition Seeks Limited Opioid Drug Indication To Curb Overuse And Abuse
Physician group appeals for FDA to rescind approval for moderate non-cancer pain and Massachusetts Democrat Rep. William Keating introduces legislation that would bar FDA approval of a non-tamper-resistant opioid drug if the same active moiety already was approved in a tamper-resistant product.
Opioid REMS Requires Sponsors To Launch Prescriber Training CME Within 9 Months
By the third year of continuing medical education efforts, FDA expects 60% of those who wrote a prescription for a long-acting/extended-release opioid in 2011 to receive training.
Companies Reveal Hurdles In Providing Drugs Via Expanded Access Programs
GSK, Stealth BioTherapeutics and Blueprint Medicines discuss the difficulties getting participation of physicians, the excessive cost of expanded access, and whether physicians should report research data.