Abuse-Deterrent Opioids: Generics Worry Comparator Standard Impedes Approvals

FDA's draft guidance could make it difficult for generics to show abuse deterrence, especially given 'moving target' of innovator labeling changes, generic firms say.

Generic firms could face hurdles in showing that their opioid products have abuse deterrence properties comparable to the innovator product, stakeholders suggest in response to FDA's draft guidance.

Edward Cone, principal scientist, drug delivery and abuse-deterrent drug products at PinneyAssociates, said the agency's call for generic companies to...

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