1. Pink Sheet

Opioid Approvals: Congress Wants US FDA Guidance On Abuse Potential

 
• By Derrick Gingery

Instead of creating new mandate, legislation tells FDA to outline how risk-benefit decisions could be influenced by a product's abuse potential under existing approval authority; final opioids package expected to reach the White House soon.

Capitol House

Rather than enumerate the power to deny or withdraw approval of a drug because of its abuse potential, Congress decided to make the US FDA describe how it will be used.

New opioids legislation mandates that the agency write guidance within one year of enactment that describes the circumstances for...

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