Abuse-Deterrent Opioids: FDA Advocates Joint Brand-Generic Development Plan

Despite ‘tension’ between two industries over what is required to show generic is no less abuse-deterrent than innovator opioid, FDA’s Throckmorton suggests they come up with single approach to product development.

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FDA is encouraging the brand and generic drug industries to come up with a unified proposal for the development of generic abuse-deterrent opioid products.

Douglas Throckmorton, deputy director for regulatory programs in FDA’s Center for Drug Evaluation and Research, advocated the approach at the...

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