FDA Exploring Partnerships As Alternative To REMS Mandate For Opioid Education
The US FDA is continuing to think through mechanisms to make opioid prescriber education mandatory – either separate from or in addition to relying on its REMS authority.
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The Opioid Is In The Mail?
The US Postal Service is suddenly a key cog in the US public health infrastructure – but don’t expect FDA to mandate mail-back packaging on opioids right away.
US FDA May Seek Legal Authority To Require Superiority Tests For Future Opioids
Commissioner Califf testifies at budget appropriations hearing that the agency may ask Congress to give it authority to require a new opioid drug application to show superiority to opioids on the market.
Opioids, Abortion, And Drug Advertising: How A Califf-Led FDA Might Address Hot Button Rx Topics
Robert Califf offers some interesting clues as to how he’d handle top drug policy issues in his Senate confirmation hearing.