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BRIEF-FDA issues final guidance on generic versions of abuse-deterrent formulation opioids‍​
November 21, 2017 / 3:46 PM / 24 days ago

BRIEF-FDA issues final guidance on generic versions of abuse-deterrent formulation opioids‍​

Nov 21 (Reuters) - U.S. Food and Drug Administration:

* Says issued final guidance to assist the industry in their development of generic versions of approved abuse-deterrent formulation opioids‍​

* Guidance has new recommendations about studies cos should conduct to show the generic drug is no less abuse-deterrent than its brand-name counterpart‍​

* Also developing testing methodologies for evaluating complex features like abuse deterrence for both brand name and generic opioid drug products

* Taking “adaptive” approach to ADF opioids evaluation, labeling, including developing new tools for expediting generic development of complex products

* New guidance will now assist generic drug developers who meet with FDA to discuss scientific, regulatory issues before submitting their applications Source text for Eikon:

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