Longer US FDA Guidance On Nitrosamine Testing Still Short Of OTC Industry’s Requests

“Control of Nitrosamine Impurities in Human Drugs” guidance, FDA’s third on the subject, adds nearly 20 pages to 2021 guidance document it revises with more extensive discussions of each topic included in the earlier guidance.

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The US Food Drug and Administration adds extensive explanations as well as recommendations in its latest guidance on testing for the presence of cancer-causing nitrosamines in active pharmaceutical ingredient but misses the points the US OTC drug industry recommends.

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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.

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.

US FDA Meets OTC Monograph Program Overhaul Deadlines But Notes Facility Fees Behind Schedule

 

FDA Office of Nonprescription Drugs explains in its proposed commitment letter for fiscal years 2026-2030, based in part on suggestions by stakeholders, that it will heighten its attention to collecting those fees.

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CDER Director Patrizia Cavazzoni Retires

 

Cavazzoni, who led the drugs center four-and-a-half years, decided on her own to retire at this time, sources said. The decision may have been a preemptive move knowing her time as head of CDER would have been limited, or at the very least highly challenging, under the new administration.

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.

Bayer And GSCF Paper Outlines ‘Practical Actions’ For Scaling Self-Care Globally

 
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Bayer Consumer Health, the Global Self-Care Federation and the Business Council for International Understanding outline in a paper how industry can work with multilateral organizations, governments, financial institutions, and stakeholders to "recognize and champion self-care as a fundamental driver of global health progress."