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‘Pervasive Contamination’ Found At Indian Eye Drop Firm Linked To Antibiotic-Resistant Infections

 
• By Malcolm Spicer

FDA also responds to sting OTC eye drop sector felt with warnings to Amazon after investigators purchased drops labeled with violative claims and a natural health care products firm with Amazon storefront offering drops with ingredient commonly used in joint health supplements and claims to “soften the membranes of the eye.”

• Source: Shutterstock

US regulators apply a major dollop of balm to the black eye the OTC eye drop sector suffered in 2023 with a warning to an Indian firm making numerous products recalled due to contaminations and linked to antibiotic-resistant bacterial infections.

The Food and Drug Administration also responded to the sting the sector’s felt with warnings to e-commerce giant Amazon Inc....

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Paying User Fees Not A Priority For Many OTC Monograph Drug Firms, First Arrears List Shows

 
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The 1,383 entries on OMUFA arrears list for facility registrations from FY2021 through FY2025 on FDA’s list exceeds its estimate of 1,134 entities subject to the fee for FY2025.

FDA Draft Guidance Waves Green Flag On Changing Color Additives For Drugs In US

 
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In a nod to drug manufacturers’ potential interest in moving to natural alternatives for petroleum-based synthetic dyes the agency intends to remove from use, document explains process for asking for approval for “any dye, pigment, or other substance that can impart color to a food, drug, cosmetic,

Over The Counter: Why OTC Firms Should Care About Rx Advertising, With AdverCheck’s James Walmsley

 
• By David Ridley

HBW Insight speaks to AdverCheck managing director James Walmsley about the rise of direct-to-consumer prescription drugs marketing in the UK, and its impact on the consumer healthcare industry.

More from Policy & Regulation

Over The Counter: How To Balance Access And Equity In Self-Care, With Bayer’s Emese Csoke

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US FDA’s Tough Talk On Talc: Regulating In An Echo Chamber

 
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An FDA “expert roundtable” on talc produced a new talking point on a potential drug safety risk, but the basis of that claim is difficult to determine.

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The 1,383 entries on OMUFA arrears list for facility registrations from FY2021 through FY2025 on FDA’s list exceeds its estimate of 1,134 entities subject to the fee for FY2025.