Tag: Food & Drug Administration
FDA Sends Warning Letter About OTC Drugs to Dollar Tree
Letter outlines corrective actions company needs to take, including ensuring they do not import impure drugs
Dr. Stephen Hahn Nominated to Head FDA
Hahn is chief medical executive of The University of Texas MD Anderson Cancer Center in Houston
FDA Committee: Makena Should Be Removed From Market
Drug was approved by FDA in 2011 to reduce risk for preterm birth in at-risk women
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
