Policy & Regulation


Who’s Running The US FDA? Interim Team May Not Have Assumed Control

 

White House expected to name Sara Brenner, chief medical officer for in vitro diagnostics at CDRH and a veteran of first Trump administration, as acting commissioner, but lack of a formal announcement is creating uncertainty. New executive orders on telework and the senior executive service also could impact agency staff.

ASA Files: ACME Vapes Case Shows Marketers Must ‘Know Their Audience’

 
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A recent ASA case involving an ad for vape products shows that marketers shouldn’t assume that professional online networks like LinkedIn are any different to other social media platforms when it comes to UK advertising codes.

Third Time Lucky? German Switch Committee Reconsiders OTC Sildenafil

 
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Today, Germany's switch committee, the SVA, will consider an application for exemption from requirement for sildenafil in 25mg and 50mg strengths. This is the third time the switch has been put to the committee, which has rejected it twice before.

Using Synthetic Dye For Cherry-Pink Shade In US Ends In 2 Years For Supplements, 3 For Oral Drugs

 

Supplement and food product firms have until January 2027 and oral drug product firms have until a year later to stop using Red No. 3, FDA decides in approving 2022 petition filed by public health advocacy groups.

Business


Eroxon-Maker Futura To Move Into Women’s Health Market

 
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Successful study results, combined with encouraging market data, prompts Futura Medical to move forward with plans to commercialize a new OTC treatment for sexual dysfunction in women. To map out the path to a US launch, the firm has already held early discussions with the FDA.

Serrix Strikes Deal With OTC Medical For Netherlands Distribution

 
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OTC Medical is now the distributor in the Netherlands of Serrix’s self-care brands, including fungal nail brand Mycosan, zinc-based cold sore treatment SoreFiX and children’s skincare brand donttellmum.

ASA Files: ACME Vapes Case Shows Marketers Must ‘Know Their Audience’

 
• By 

A recent ASA case involving an ad for vape products shows that marketers shouldn’t assume that professional online networks like LinkedIn are any different to other social media platforms when it comes to UK advertising codes.

US Q4 Consumer Health Earnings Preview: Executive, ‘Playbook’ And ‘Fundamental’ Changes

 

Industry’s results from October-December period start on 22 January with Procter & Gamble reporting its fiscal year 2025 second-quarter numbers and Abbott with its 2024 full-year and fourth-quarter information.

Innovation & IP


Eroxon-Maker Futura To Move Into Women’s Health Market

 
• By 

Successful study results, combined with encouraging market data, prompts Futura Medical to move forward with plans to commercialize a new OTC treatment for sexual dysfunction in women. To map out the path to a US launch, the firm has already held early discussions with the FDA.

Third Time Lucky? German Switch Committee Reconsiders OTC Sildenafil

 
• By 

Today, Germany's switch committee, the SVA, will consider an application for exemption from requirement for sildenafil in 25mg and 50mg strengths. This is the third time the switch has been put to the committee, which has rejected it twice before.

Opella Partners With Climate Data Firm To Create Allevia-Branded ‘Pollen Passport’

 
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Developed using Datair's Ambee climate data technology, Opella’s Pollen Passport presents users with an easy to use and interactive online visualization of air quality at holiday destinations across the world.

OTC Sildenafil Not Coming To Australia Any Time Soon

 
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Australian government finds an insufficient body of new evidence to support Rx-to-OTC switch of erectile dysfunction drug sildenafil since it was last considered in 2020.

Rx-to-OTC Switch


First Green Light In US For ED Drug OTC Switch Actual Use Trial Goes To Opella For Cialis

 

Opella says FDA “lifted a clinical hold on its planned actual use trial to support the switch of Cialis” while Petros Pharmaceuticals shifts from working on its own ED-switch proposals to developing a proprietary technology-assisted platform designed for use in consumers’ self-selection of drugs made available in ACNU proposals.

Third Time Lucky? German Switch Committee Reconsiders OTC Sildenafil

 
• By 

Today, Germany's switch committee, the SVA, will consider an application for exemption from requirement for sildenafil in 25mg and 50mg strengths. This is the third time the switch has been put to the committee, which has rejected it twice before.

OTC Sildenafil Not Coming To Australia Any Time Soon

 
• By 

Australian government finds an insufficient body of new evidence to support Rx-to-OTC switch of erectile dysfunction drug sildenafil since it was last considered in 2020.