FDA finalizes opioid

The FDA issued final guidance for abuse-deterrent opioid evaluation and labeling in April, two years after issuing draft guidance and a little over two months before the June 30 deadline that would have cost the agency $20 million if it had failed to deliver. Dr. Douglas Throckmorton, deputy directo...

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Veröffentlicht in:Medical Marketing and Media 2015-05, Vol.50 (5), p.12
1. Verfasser: Weinstein, Deborah
Format: Artikel
Sprache:eng
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Zusammenfassung:The FDA issued final guidance for abuse-deterrent opioid evaluation and labeling in April, two years after issuing draft guidance and a little over two months before the June 30 deadline that would have cost the agency $20 million if it had failed to deliver. Dr. Douglas Throckmorton, deputy director of regulatory programs at the Center for Drug Evaluation and Research, said the guidance was issued because of its importance. He added that the agency "worked as quickly as it could." An abuse-deterrent formula that is formulated to discourage crushing would render the drug unusable for those patients.
ISSN:0025-7354