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20 Democrat, 1 GOP State AGs Frame OTC Birth Control Within Protecting Reproductive Rights

 
• By Lauren Nardella

Citing national uncertainty regarding reproductive health care – “ a time when reproductive rights have been curtailed across the country – state AGs urge FDA to approve OTC birth control proposal from HRA Pharma.

• Source: Shutterstock

The US Food and Drug Administration must preserve women’s access to reproductive health care and approve OTC access to birth control pills which meet safety and efficacy standards, attorneys general from 21 states urge agency Commissioner Robert Califf.

A letter sent on 3 November by 20 Democrat and one Republican state attorneys general in response to FDA’s request for comments on HRA Pharma’s new drug application to...

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

 
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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.

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

 
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At the second attempt, New Zealand’s Medicines Classification Committee supported the Rx-to-OTC switch of allopurinol (100mg and 300mg) for people suffering from gout by specifically trained pharmacists.

Over The Counter: Everything You Wanted To Know About Real World Evidence, With IQVIA’s Volker Spitzer

 
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HBW Insight finds out all about real world evidence and its potential for the OTC industry by chatting with IQVIA Consumer Health's vice president of global research and development and real-world evidence services, Volker Spitzer.

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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People On The Move: Appointments At ANEPF, Inula, Opella

 
• By Tom Gallen

A round-up of the latest consumer health people moves: ANEFP elects president; Inula Group appoints CEO; Opella names ANZ head.

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

 
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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.”