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BioPharmaceutical United States Advisory Committees

When Is An Abuse-Deterrent Claim FDA Approved?

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Executive Summary

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.

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Abuse Deterrence: US Exclusivity Update May Ride User Fee Coattails

CDER's Woodcock suggests exclusivity rules outdated for abuse-deterrent technology development, and Rep. Griffith takes it to mean legal changes are needed.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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