Tag: Food & Drug Administration
FDA Labeling Restriction Quickly Reflected in Oncology Practice
FDA label change linked to decrease in immunotherapy use, increases in chemotherapy use, PD-L1 testing
FDA: Smokeless Tobacco Snus Can Be Marketed as Less Risky Than Cigarettes
This is the first time the FDA has allowed product marketing of this type
FDA May Put Strong Warning on Breast Implants
Agency suggests boxed warning, checklist outlining potential harms, such as pain, fatigue, further surgery
New Alzheimer Disease Drug to Be Submitted for FDA Approval
New analysis of study results suggests highest dose of aducanumab may help slow cognitive decline
Maker Halts Distribution of Generic Zantac Due to Possible Carcinogen
Preliminary tests revealed low levels of the nitrosamine impurity NDMA in some ranitidine products
FDA Warns Juul About Illegal Marketing Claims, Pitch to Youth
FDA questions claims such as Juul is 'much safer than cigarettes' and the 'FDA would approve it any day'
FDA Reports Rare Cases of Liver Injury, Failure With Hep C Therapies
Worsening liver functioning, liver failure reported among patients contraindicated for HCV therapies
‘Miracle Mineral Solution’ Is No Miracle Cure, FDA Warns
When mixed, the solution develops into a dangerous bleach
FDA: Approval of Zolgensma Was Based on Manipulated Data
Despite inaccurate data, FDA says it is 'confident that Zolgensma should remain on the market'
FDA: Blood Clot, Death Risk Up With Higher Dose of Tofacitinib
Increased risk seen with 10 mg dose of tofacitinib used for treating ulcerative colitis
