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Nozzle At Tip Of Problems For Florida Eye Drop Firm: US FDA Warns Of GMP, Monograph Violations

 
• By Malcolm Spicer

Regenerative Processing replaces nozzle to prevent backflow for its Regener-Eyes drops but FDA warning states numerous questions about sterility at the firm’s plant and about its procedures and systems for preventing microbial contamination.

• Source: Shutterstock/Citeline

A Florida firm recently announced it replaced the nozzle on its OTC eye drops with one that prevents backflow without explaining that the change came after the Food and Drug Administration questioned the safety of its products while suggesting a recall may be necessary.

Regenerative Processing Plant LLC on 25 September said the multi-part nozzle to prevent backflow for its Regener-Eyes (glycerin 0

Social Media For Eye Health, Scientific Recognition For CEO

Rolling out a new eye drop nozzle isn’t Regenerative Processing’s only announcement since the FDA inspection.

In August 2023, it unveiled its Social-Eyes social media collective to redefine eye health awareness, bringing together the power of social media and the expertise of top eye care professionals to promote eye health.

And two months later, it announced that chief scientist and CEO C. Randall Harrell was included in the top 2% of scientists worldwide recognized by Stanford University and Elsevier and based on numbers of papers and citations

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

 
• By David Ridley

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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.

EU Parliament Calls For Review Of Wastewater Directive’s Impact On Pharma Sector

 
• By David Ridley

At a recent plenary session the European Parliament adopted a resolution calling on the European Commission to “conduct a new and comprehensive assessment” of the impact of the revised Urban Wastewater Treatment Directive on the pharmaceutical sector.

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.

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EU Parliament Calls For Review Of Wastewater Directive’s Impact On Pharma Sector

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

 
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Global Alliance Urges UN General Assembly To Put Self-Care At Centre Of NCD Strategy

 
• By David Ridley

Including self-care in an upcoming UN General Assembly political declaration would be a “powerful signal that the global community is serious about non-communicable disease prevention and control,” argues the United for Self-Care Coalition, which includes the Global Self-Care Federation, International Self-Care Foundation and Imperial College London’s Self-Care Academic Research Unit.