FDA Draft Guidance Would Require Abuse Deterrence For Generic Opioid Drugs

(March 25, 2016, 8:52 AM EDT) -- SILVER SPRING, Md. — The Food and Drug Administration on March 24 said it has issued a draft guidance that would require makers of generic opioid drugs to develop abuse-deterrent formulations.

The FDA said generic versions of opioids should be no less abuse-deterrent than brand-name opioid drugs. The agency said the draft guidance recommends that generic drug makers conduct studies to demonstrate abuse deterrence.

The FDA said a public meeting will be held later this year to discuss the draft guidance.

Opioids can be abused by...
To view the full article, register now.