FDA ulcer and burn guidance
This article was originally published in The Tan Sheet
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 The notice finalizes the draft guidance put out by FDA on the subject in June 2000, the agency states.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 FDA has considered comments received from industry, professional and consumer groups on the draft guidance and has made some changes to the final guidance.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...
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