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 The notice finalizes the draft guidance put out by FDA on the subject in June 2000, the agency states.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 FDA has considered comments received from industry, professional and consumer groups on the draft guidance and has made some changes to the final guidance.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...
You may also be interested in...
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.