Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
FDA draft guidance explains the difference between recalls and product enhancements. Proposed rule on non-U.S. studies. More regulatory news.
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FDA Recalls Guidance Seeks To Allay Manufacturer Anxieties About Device Safety Enhancements
A new draft guidance tries to reassure manufacturers that they can make changes to improve a device's performance or safety without fear that FDA will necessarily require a recall. But early reactions suggest industry may not be happy with at least one component of the document.
FDA Warns Abiomed About Unlawful Promotion Of Impella Cardiac Pump
FDA says Abiomed is promoting its top-selling Impella 2.5 cardiac pump for unapproved uses, and sent a warning letter to the firm June 10.
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.