1. Pink Sheet

New Opioids: FDA Should Ditch 'Product-Specific Approach,' Science Report Says

 
• By Brenda Sandburg

FDA-commissioned study recommends agency consider things like off-label use and risks of transition to illicit drugs in opioid approval decisions; opposes restricting market to abuse deterrent formulations.

Opioid abuse epidemic concept

A new report on the opioid epidemic recommends that FDA change its approach to making approval decisions for new opioids to consider such things as effects on the overall market for legal opioids and the risks of transitioning to illegal products such as heroin.

"The FDA traditionally has taken a product-specific approach to drug approval decisions by focusing on the data generated and submitted by a drug's manufacturer and balancing the benefits against the risks known (and unknown) at the time of the agency's review," the

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• By Francesca Bruce

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England: HTA Sandbox Helping To Assess ‘Challenging’ Drugs And Indications

 
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