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Will Influences Behind US FDA's Delayed Approval For OTC Plan B Also Shadow ‘Plan A’ Switch?

 
• By Malcolm Spicer

FDA history with emergency contraceptives and opioid overdose antidote naloxone doesn’t assure Jeffrey Singer, Valley Surgical Clinics founder and advocate for making more drugs available OTC, the agency will approve HRA Pharma's NDA for OTC 0.075-mg norgestrel.

• Source: Shutterstock

An Arizona surgeon and advocate for making more pharmaceutical products available OTC isn’t sure the Food and Drug Administration is ready to approve the change for a drug he’s singled out as a prime candidate, daily oral contraceptives.

The FDA’s history with emergency contraceptives and with opioid overdose antidote naloxone doesn’t assure Jeffrey Singer, president emeritus and founder of Valley Surgical Clinics Ltd

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New Zealand Could Become First Country To Offer Gout Drug Allopurinol OTC

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

 
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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.