Opioid Emergency Clears Supply Chain Security Impediments To Naloxone Distribution
The groups on the front lines of the opioid epidemic may not be physicians or pharmacists or drug wholesalers, but they are the ones that need to receive naloxone if it is to do any good. Latest US FDA guidance removes one of the impediments.
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FDA and non-profit firm Harm Reduction Therapeutics head Michael Hufford agree consumers could pay more out-of-pocket for OTC product than they do in co-pays for insurance plans. But Hufford says consumers’ costs for HRT’s OTC naloxone product won’t be impediment to expanding access.
Responses to US FDA draft guidance suggest more promptness while also more elaborate processes for agency decision making based on remote methods. Questions include what’s voluntary, what’s mandatory, what can be decided remotely, and how to remotely move on from warning letters.
Memo outlines how US agency ensured sufficient delivery of updated COVID-19 vaccine doses even as it navigated unresolved inspection findings of the Catalent plant where the additional doses had been manufactured.