HBW Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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

Lucky STAR: FDA’s eSTAR Pilot Aims To Make 510(k) Process Smoother With Submission Template For Device Makers

Nine manufacturers will soon have the chance to enroll in a voluntary eSTAR pilot program that the US agency says will make the premarket review process more efficient and consistent. The design and structure of an electronic Submission Template And Resource – or eSTAR – template is similar to templates used by FDA reviewers. An eSTAR won’t change the agency’s statutory or data requirements for sponsors to show substantial equivalence to predicate devices.

UsernamePublicRestriction

Register

RS009829

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel