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Expanding Naloxone Access Needs Normalizing First-Aid Use, Keeping Purchase Records Private

 
• By Hannah Daniel

Opposition to making naloxone available OTC remains strident because of stigma surrounding drug overdoses, says Bobby Mukkamala, a head and neck surgeon and an AMA Board of Trustees member.

• Source: Alamy

Normalizing naloxone as a first-aid tool and keeping information on sales of the opioid antagonist private are needed for expanding access and use in addition to OTC switch applications, according to emergency medicine and overdose prevention experts

Naloxone isn’t a controlled substance and has no potential for abuse yet opposition to making it available OTC remains strident because of stigma surrounding drug overdoses, said Bobby Mukkamala, a head and neck surgeon and an American Medical Association Board of Trustees member

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Trump Order To Improve Making More Drugs Available OTC Puts Wind Behind Petros’ ACNU Sails

 
• By Malcolm Spicer

Petros will incorporate into its platform an analytics firm’s automated document capture and authentication system leveraging its global ID library to verify identity and eligibility of consumers accessing the self-selection process for an ACNU switch.

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Over The Counter: Taking Real-World Evidence Seriously, With IQVIA Consumer Health’s Volker Spitzer

 
• By David Ridley

In part 2 of HBW Insight's interview, IQVIA Consumer Health's vice president of global research and development and real-world evidence services, Volker Spitzer, explains how to approach real world evidence so that regulators recognize its validity, in supporting Rx-to-OTC switch applications, for example.

Value Of Consumer Wearables Within The Clinic Currently Unknown, Says Cardiologist

 
• By Natasha Barrow

“It’s quite likely [consumer wearable manufacturers] are changing the sensitivity and specificity based on consumer feedback, but not for medical reasons,” said Dipak Kotecha, a University of Birmingham professor of cardiology. Often, self-reported performance evidence from manufacturers is “low quality and biased.”

US FDA Expands Surprise Foreign Inspections

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.