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‘Shadow’ Factory Challenges Continue For US FDA

 
• By Bowman Cox

Agency wants more information about API suppliers as it winds up case against KV Tech for hidden use of Dr. Reddy’s plant and seeks to find disappearing manufacturer of contaminated OTC eye drops.

Show and shadown factories
• Source: Shutterstock

The Food and Drug Administration has shown in recent actions that hidden, substandard facilities continue to manufacture adulterated drugs available in the US, violations the agency is pressing Congress for authority for stronger ability to identify those facilities.

Included in FDA officials’ recent investigations are two manufacturers of OTC drugs, one with a Florida facility making eye drops...

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FDA Draft Guidance Waves Green Flag On Changing Color Additives For Drugs In US

 
• By Malcolm Spicer

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.

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

 
• By David Ridley

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 Proposal To Remove Phenylephrine From OTC Monograph Could Stress-Test Streamlined Process

 
• By Malcolm Spicer

Proposed administrative order likely is first to prompt opposition from OTC industry or other stakeholders potentially delaying or deferring the agency’s expectation for moving its proposal to a deemed final order effective one year after it would be published.

More from Policy & Regulation

FDA Takes World Tour In Recent OTC Warnings

 
• By Malcolm Spicer

FDA Center for Drug Evaluation and Research Office of Manufacturing Quality, Office of Compliance and Office of Unapproved Drugs & Labeling Compliance recently advise Indian, Canadian and US firms about GMP problems.

German Associations Call For EU Green Claims Directive Trilogue Suspension

 
• By David Ridley

Pharma Deutschland is one of 21 German associations calling for trilogue negotiations in relation to the EU Green Claims Directive to be suspended while a “comprehensive and independent written impact assessment” is undertaken.

Over The Counter: EU Omnibus And ESG, What You Need To Know, With CEN Group’s Jasper Crone

 
• By David Ridley

HBW Insight catches up with sustainability expert Jasper Crone to find out what consumer health companies need to know about the European Commission's Omnibus simplification package.