A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety.

Summary

This bill requires the Food and Drug Administration (FDA) to develop guidance regarding how it will assess evidence to support claims of opioid sparing (i.e., the use of drugs that reduce pain while also allowing reduced use or avoidance of oral opioids) for non-opioid or other non-addictive medical products intended to treat pain. The FDA must also develop guidance regarding how it will consider the misuse and abuse of drugs in making certain determinations of safety.

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Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 12 April 2018

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 12 April 2018

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• Introduced in Senate

  summary · EN · 12 April 2018

  Open at official source

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