Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
News from FDA, the Government Accountability Office and the Federal Trade Commission.
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FDA To Survey Clinicians About Adding “Highlights” Section To Device Labeling
FDA wants to know what information physicians, nurses and technicians would like to see in a shortened "quick guide" version of labeling as part of an effort that could result in more standardized device labeling.
Devices In The Home: FDA Panel Explores New Ways To Provide Instructions
As medical devices move out of the hands of trained health professionals and into the home, FDA and manufacturers need to find new ways to teach people how to use them safely, according to agency advisors.
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.