Medtech 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

Cattle material in OTCs

This article was originally published in The Tan Sheet

Executive Summary

An FDA proposed rule would prohibit the use of certain cattle materials in drugs and homeopathics to prevent the spread of bovine spongiform encephalopathy, according to a Federal Register notice published Jan. 12. The list of materials prohibited from use includes items such as the brain, skull, eyes and spinal cord from cattle 30 months and older. The notice points out homeopathic preparations and OTCs approved through the monograph process will be required to comply with the rule, even though they have not been approved through a new drug application. "Although FDA's database of these products is incomplete, some of them may contain cattle materials that would be prohibited under this proposed rule. The requirements proposed...apply to all drugs for humans, including those marketed without an approved application," the notice states. Comments on the proposed rule are due by March 13...

You may also be interested in...



QUOTED. 30 November 2020. David Hoffmeister.

A recent Department of Health and Human Services proposal to review regulations every 10 years may mean good things for the device industry, said David Hoffmeister, partner, Wilson Sonsini Goodrich & Rosati.

Aker BioMarine Plans US NDI Notification For EPA/DHA Formulated To Pass Blood-Brain Barrier

Aker BioMarine seeks supplement firms to use its EPA/DHA innovation bound by lysophosphatidylcholine to enable the fatty acids to pass through the blood-brain and blood-retinal barriers and boost of eye and brain health benefits. It will submit an NDI notificaion in the US during 2022.

EWG Study Suggests More Than One In 10 Talc-Based Cosmetics Contain Asbestos

The Environmental Working Group and Scientific Analytical Institute say inadequate testing of talc-containing personal-care products is to blame for findings of asbestos in cosmetics, including three of 21 powder-based cosmetics SAI analyzed at EWG’s request. They continue to push for updated testing standards that include electron microscopy as a core component.

Topics

UsernamePublicRestriction

Register

OM006145

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