FDA review of benzethonium chloride
This article was originally published in The Rose Sheet
Executive Summary
Evaluation of data submitted by Lonza to support its request that benzethonium chloride be classified a Category I active ingredient in the healthcare antiseptics monograph will be included in final rule, FDA tells the firm in a Nov. 5 letter. "The agency intends to fully consider all relevant data on benzethonium chloride available to us before making a decision on the ingredient's status in the final rule," letter says. However, FDA adds, because the agency is developing the rule, it is required to limit communication with interested parties and is unable to meet with Lonza on the subject. Chemical ingredient supplier requested FDA complete a safety review of benzethonium chloride prior to finalizing the rule in a Sept. 17 letter (1"The Rose Sheet" Oct. 29, p. 8)...
You may also be interested in...
ABC Compounding Changes Sanitizer Labeling In Response To FDA
ABC Compounding Company has omitted the statements "requires no water," "requires no soap and water" and "use as needed between hand washes to help reduce bacteria on the skin" on labeling for its QS Plus Instant Hand Sanitizer in response to a warning letter from FDA
Benzethonium Chloride Finished Product Studies Support Efficacy – Lonza
Safety and efficacy studies on the use of benzethonium chloride in finished product formulas support a Category I classification of the ingredient in the healthcare antiseptic monograph, chemical supplier Lonza says in a May 15 citizen petition to FDA
US FDA Drugs Center Ready To Break Down Silos On Regulatory Innovation
CDER Director Cavazzoni is promising to increase coordination and collaboration to accelerate broader adoption of innovative clinical trial designs and other approaches to speed drug development. A new "Quantitative Medicine Center of Excellence" illustrates the approach.