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Making Progress On Novel OTC Switch Rulemaking Has FDA Commissioner Nominee Califf’s Attention

 
• By Malcolm Spicer

Responding to Sen. Roger Marshall’s question on rulemaking to accelerate OTC switches by allowing NDA sponsors to use extra-label information to guide consumers through self-selection of a drug, Robert Califf said he’d support making progress on a proposal FDA began considering in 2012 in its NSURE initiative.

Robert Califf in fornt of FDA building
• Source: FDA images combined

Robert Califf’s likely confirmation by the Senate would send him to the Food and Drug Administration commissioner post with him “mindful” that modernizing the agency’s Rx-to-OTC switch paradigm has been a regulatory goal for a decade.

Califf, who previously was commissioner for 11 months ending in January 2017, answered Health, Education, Labor and Pensions Committee members questions during a December hearing and in writing. The committee...

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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.

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

 
• By David Ridley

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

 
• By David Ridley

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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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.