Regulatory News Roundup
This article was originally published in The Tan Sheet
Executive Summary
E-cigarette “Love” claim misleading; time for proprietary names comment; more supplement adulterations, contaminations.
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U.K. E-Cigarettes Can Make Smoking Alternative Claim, But Not Healthier
NJOY ads “implied that the product was favorable to smoking tobacco cigarettes,” but “there may be a number of reasons why a friend might suggest the product as an alternative to smoking tobacco cigarettes,” U.K. advertising watchdog says.
Draft Guidance On Developing Drug Names Calls For Simulation Studies
FDA’s draft guidance on developing proprietary drug names recommends steps to evaluate a proposed name, including testing names with health care professionals. The draft notes that OTC “brand name extensions have posed problems when the same root proprietary name is used for multiple products.”
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.