The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products.'' This draft guidance recommends studies, including comparative in vitro studies, which should be conducted to demonstrate that a proposed generic solid oral opioid drug product is no less abuse-deterrent than its reference listed drug.
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General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drugs Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``General Principles for Evaluating the Abuse Deterrence of Gener...
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81 FR 16186
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“General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drugs Products; Draft Guidance for Industry; Availability,” thefederalregister.org (March 25, 2016), https://thefederalregister.org/documents/2016-06766/general-principles-for-evaluating-the-abuse-deterrence-of-generic-solid-oral-opioid-drugs-products-draft-guidance-for-in.