New Opioid Approval Standard Intended To Drive Development Into Other Therapeutics

US FDA explored whether existing law allowed for the higher standard, but determined new authority granted by Congress was necessary.

opioid pills and syringes
The FDA wants Congress to give it authority to set a higher bar for opioid approval. • Source: Shutterstock

The US Food and Drug Administration is hoping its proposed new opioid approval standard will alter the course of pain therapeutic development.

The FDA’s Overdose Prevention Framework includes exploration of changes to opioid approval standards so new products are judged on...

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