When Is An Abuse-Deterrent Claim FDA Approved?

Agency says it is seeing confusion in the marketplace when it comes to distinguishing between agency-approved labeling claims and advertising about products that are intended to be abuse deterrent.

FDA draws a bright line between abuse-deterrent claims that satisfy its 2015 guidance document and those that do not, but the distinction is not always clear to those outside the agency.

The potential for confusion about what is and is not an abuse-deterrent opioid product under the guidance was evident at...

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