Pink Sheet is part of the Business Intelligence Division 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 ulcer and burn guidance

This article was originally published in The Tan Sheet

Executive Summary

A new guidance for industry entitled "Chronic Cutaneous Ulcer and Burn Wounds - Developing Products for Treatment" is now available, according to a June 2 Federal Register notice. The notice finalizes the draft guidance put out by FDA on the subject in June 2000, the agency states. In addition to providing recommendations about developing burn and ulcer treatments, the guidance includes information about designs for clinical trials and preclinical and manufacturing considerations. FDA has considered comments received from industry, professional and consumer groups on the draft guidance and has made some changes to the final guidance. The agency will continue to accept comments on the guidance on an open-ended basis...
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

PS099435

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