1. HBW Insight
  2. >>Health
  3. >>Policy & Regulation
  4. >>Compliance

For US FDA, ‘History Is Again Repeating’ With International Diethylene Glycol Poisoning Outbreak

 
• By Malcolm Spicer

CDER manufacturing quality director notes origin of Food, Drug and Cosmetic Act in 1938 is linked to DEG/EG poisoning. FDA says current outbreak in at least seven countries “one of the largest epidemics of DEG and EG poisoning in history.”

• Source: Shutterstock

Recent US Food and Drug Administration warnings to foreign and domestic OTC drug firms about failing to test ingredients for diethylene glycol and ethylene glycol substitution are the latest indications that, as an agency official says, ‘“sadly, FDA has a long history with DEG/EG poisonings.”

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Compliance

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.

Perrigo’s Formula To Drive Earnings Rebound Swings On Further Formula Business Recovery

 
• By Malcolm Spicer

“The infant formula business is recovering and we've taken actions to simplify and consumerize our business, but there's a lot more work to do,” says CEO Patrick Lockwood-Taylor as Perrigo’s announced latest results.

More from Policy & Regulation

Plenty For Industry To Do As EU Wastewater Directive Faces Legal Challenges

 
• By David Ridley

Engaging with EU member state legislators, stressing the impact of national EPR systems on the accessibility, availability, and affordability of medicines, reformulating products to reduce their financial contribution, and lobbying for expanding the scope of EPR schemes to include other polluting industries are all ways that the European consumer health industry can try and influence the way that the revised Urban Wastewater Treatment Directive is transposed into national legislation, law firm Mason Hayes & Curran explains.

US FDA Allows Telework For Reviewers As Companies Detail Layoff-Related Problems

 
• By Derrick Gingery

The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.

EU Parliament Agrees To Postpone Due Diligence And Sustainability Reporting Rules

 
• By David Ridley

Speaking at a recent AESGP webinar, sustainability expert Onur Durmus called the the European Commission’s “Omnibus” proposals - designed to simplify ESG reporting rules and recently supported by EU Parliament - a “positive development” for the European consumer health industry.