Tests On Professional Antiseptics Could Influence Consumer Hand Wash Market

Responding to industry's requests, US FDA's rulemaking on six health care personnel antiseptics remaining in the OTC drug monograph is delayed one year to allow firms to demonstrate the ingredients are GRASE. ACI says the research could impact whether ingredients remain available for consumer hand washes.

The additional year FDA is allowing for research on the safety of six antiseptic ingredients in health care personnel hand washes could generate data that determine whether three of the ingredients also will remain available in consumer hand rubs.

FDA's Center for Drug Evaluation and Research granted the extension in response to manufacturers' requests for more time to complete...

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 Drug Safety

MHRA Investigates GLP-1 And Pancreatitis Genetic Link In Personalized Medicine Push

 

The UK drug regulator is collecting data to establish whether patients who are hospitalized for acute pancreatitis after taking a GLP-1 drug have a genetic predisposition to this side effect. If a “clear link” is found, the MHRA would consider regulatory action.

Titanium Dioxide Stays: EU Decides Not To Pull Plug On Widely Used Excipient

 

While titanium dioxide is banned as a food additive in the EU, the European Medicines Agency has convinced the European Commission to allow its continued use in the many thousands of medicines in which it is currently used.

New EU Drug Safety Rules Scrap Signal Detection Pilot, Boost Audit & Subcontracting Controls

 
• By 

The European Commission has adopted new rules to cut red tape in pharmacovigilance, tighten oversight of outsourced drug safety activities, and ensure a balanced approach to signal detection, boosting both efficiency and patient safety.

Sarepta Will Resume US Elevidys Shipments For Ambulatory DMD Patients After FDA Reverses Course

 
• By 

The FDA recommended removal of a voluntary hold on shipments of the gene therapy to younger patients after finding that the death of an 8-year-old boy in Brazil was unrelated to Elevidys. Discussions on safety of DMD treatment for non-ambulatory patients is ongoing.

More from Pink Sheet

Japan To Cut Leqembi Price By 15% Following Cost Effectiveness Review

 
• By 

While Japanese government announces 8-15% price cuts for four drugs, including Leqembi, industry groups urge operational improvements to national cost effectiveness assessment scheme.

Precigen’s Papzimeous Approval Allows US FDA CBER Director To Emphasize Flexibility

 

Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.

Generic Drug Industry Seeks More US FDA Communication Reforms In GDUFA Renewal

 
• By 

Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.