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No ‘Surprise’ Facility Fees For Sanitizer Makers After Responding To COVID-19 Emergency In US

 
• By Malcolm Spicer

HHS says FDA made subject to monograph program facility fees businesses that began making hand sanitizers in response to temporary guidance easing manufacturing standards "about the same time” the department withdrew the user fee schedule.

The US user fee schedule for OTC monograph drug manufacturers will get the Department of Health and Human Services secretary’s approval when “small businesses who stepped up to fight COVID-19” by making hand sanitizers are excluded.

After withdrawing the Food and Drug Administration’s fiscal year 2021 user fee schedule for firms registered as manufacturers of OTC drugs that are available under the agency’s monograph program on 4 January, the HHS the next day said the FDA

The HHS, in a notice prepared for publication in the Federal Register, also stated that the FDA had added to its website an explanation saying businesses that began making OTC hand sanitizers after the agency in March 2020 temporarily eased manufacturing standards to encourage additional production to

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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.

Melatonin And Buccal Acyclovir On German Switch Committee Agenda

 
• By David Ridley

An application for melatonin as an OTC medicine is on the agenda for the next German switch committee meeting, despite the hormone being widely available in food supplements. Acyclovir as a buccal tablet and second-generation antihistamine rupatadine are also up for discussion.

Over The Counter: Brands, Brexit And New Self-Care Business Models, With PAGB’s Michelle Riddalls

 
• By David Ridley

HBW Insight catches up with UK OTC industry association CEO Michelle Riddalls to talk about digital self-care and the unrealized promise of Brexit - part 2.

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