Pink Sheet 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

Fluoride dental floss

Executive Summary

FDA should amend OTC Anticaries Drug Products TFM to disallow "the OTC marketing of sodium fluoride treated dental floss in the absence of clinical data showing superiority over comparable floss" without the cavity-fighting ingredient, Squibb unit Princeton Pharmaceuticals argues in a Nov. 14 petition. Firm maintains GRAS/E status of fluoride cannot be extended to a medical device (floss) on bioequivalency grounds as proposed by Johnson & Johnson in a July 1986 petition. J&J argued that dental floss can deliver fluoride with efficacy comparable to other methods of application ....

You may also be interested in...



Keeping Track: Submissions Galore Start The New Year; US FDA Clears New Indications For Enhertu, Xalkori

The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker

Vaccination Health Next Stop For Dentovations’ Self+ Immunity Supplement Line

Vacci Prep is first “supplement to establish a standard of care for consumers when preparing their immune system for vaccinations,” Dentovations says.

Balancing Innovation And Safety – The US and Australian Medtech Regulatory Systems Compared

Effective medical device regulation supports both safety and innovation needs. This article assesses how well the US FDA and the Australian TGA achieve this balance.

UsernamePublicRestriction

Register

OM017175

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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