Scrip 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

US FDA classifies dressings containing pDADMAC as Class II

This article was originally published in RAJ Devices

Executive Summary

The US Food and Drug Administration is classifying wound dressings that contain the additive poly (diallyl dimethyl ammonium chloride) as Class II devices and has issued a guidance document on special controls that must be followed by manufacturers intending to market such products1-3.

You may also be interested in...



No English Funding For Lymphoma Drugs Ledaga and Poteligeo

Limitations in the design of the clinical trials that were carried out for each drug are among the concerns highlighted by the health technology assessment body in two interim guidances that are now out for consultation.

New EU Approvals

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include eight new products, including Roche's Rozlytrek (entrectinib) for the histology-independent indication of treatment of patients with NTRK fusion-positive solid tumors, and for treating patients with ROS1-positive advanced non-small cell lung cancer. The list, which contains information dating back to January 2018, comprises brand name, generic name, company, therapeutic indication, date of marketing authorization announcement and product type (eg, medicine, vaccine, biologic).

Global Regulators Agree On Acceptable Trial Endpoints For COVID-19 Treatments

International regulators have agreed on primary endpoints that would be suitable for assessing the clinical benefit of an investigational therapeutic for COVID-19 and support regulatory approval.

UsernamePublicRestriction

Register

SC031354

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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