
The U.S. Food and Drug Administration (FDA) has reprimanded Bristol Myers Squibb for making false and misleading claims regarding the efficacy of its lung cancer treatment, Krazati. The FDA's criticism is centered around a misleading website aimed at healthcare professionals. The issue arose from the misrepresentation of data from a single-arm study, which led to the misleading claims about the treatment's effectiveness.
Our @SarahKarlin's looks at the latest @US_FDA ad/promo enforcement letter ... @PharmaPinkSheet #pinksheet #pharma: Misconstruing Single-Arm Study Data Lands BMS In Trouble With US FDA https://t.co/5RyrqUA278
For your PDUFA radar ... @PharmaPinkSheet #pinksheet #pharma: How Math Errors May Have Cost US FDA Millions In PDUFA Fees https://t.co/7F2ARvRCf0
Misconstruing Single-Arm Study Data Lands BMS In Trouble With US FDA https://t.co/6ThOcyWCWx #PinkSheet
