In Brief

FDA softens disclaimer for green tea QHC; Formulife/Purus covers spectrum of violations; NAD refers Schick case to FTC; Genomma drops Prestige Brands board bid.

FDA gives sunscreen makers an eleventh-hour extension to comply with new labeling and effectiveness testing requirements. The agency pushed back the deadline by six months for sunscreen products to undergo broad spectrum testing and amend label claims to reflect the test results. Firms now must test and revise packaging by Dec. 17, 2012, for all products with annual sales of $25,000 and up, and by Dec. 17, 2013, for other products, according to a notice in the May 11 Federal Register. FDA extended the deadline after the Consumer Healthcare Products Association and the Personal Care Products Council argued broad spectrum testing for all the sunscreen products would require at least 10 months due to the limited capacity of testing facilities and that complex label redesigns, such as on glass or plastic containers, would take longer than the one year the agency originally granted. Without a delay, the trade groups also argued, firms might pull their products from the market until they complied, which would result in a sunscreen shortage Also see "Industry Needs More Time To Comply With Sunscreen Testing, Labeling Rule" - Pink Sheet, 29 August, 2011..

FDA grants Fleminger Inc. a less-restrictive qualified health claim for its green tea products, following a federal court order that...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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

More from Europe

UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
• By 

The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.

Blenrep’s Comeback Continues As England Becomes First To Fund Drug

 

Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.

Pharma’s Protests Fall Flat As UK Locks In High Rebate Rates

 

Despite pushback by industry, the government is standing by its new statutory scheme rebate rates for branded medicines, including one that doubles the rate that companies must repay on the sales of newer products to the National Health Service to 31.3%.

EUCOPE Wants Simpler Manufacturing Rules And Framework For Combined Trials Under EU Biotech Act

 

EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.

More from Geography

Recent And Upcoming FDA Advisory Committee Meetings

 
• By 

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
• By 

The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.

Blenrep’s Comeback Continues As England Becomes First To Fund Drug

 

Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.