Home Tags Food & Drug Administration

Tag: Food & Drug Administration

Compliance with the U.S. Food and Drug Administration Amendments Act of 2007 is low

Fewer Than Half of Clinical Trials Comply With Reporting Laws

Compliance with Food and Drug Administration Amendments Act of 2007 low, not improving
The U.S. approval and regulation processes for pharmaceutical agents have evolved during the last four decades

Evolution of Approval, Regulation Processes for Drugs Explored

FDA drug review times down from 1983 to 2017, but time from clinical testing to approval did not change
The U.S. Food and Drug Administration on Tuesday approved the sale of two reduced-nicotine cigarettes.

FDA Approves Sale of Low-Nicotine Cigarettes

Nicotine content of the two newly approved cigarettes is less than 1 mg per cigarette
Stephen Hahn

Hahn Confirmed as New FDA Chief

One major challenge facing Hahn is the teen vaping epidemic
Dollar Tree has been sent a warning letter for selling over-the-counter drugs made by foreign companies with serious

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
Radiation oncology expert Stephen Hahn

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
The June 2018 U.S. Food and Drug Administration label restriction on first-line immunotherapy for advanced bladder cancer was associated with a decrease in immunotherapy use and an increase in chemotherapy use

FDA Labeling Restriction Quickly Reflected in Oncology Practice

FDA label change linked to decrease in immunotherapy use, increases in chemotherapy use, PD-L1 testing
U.S. health groups are slamming the U.S. Food and Drug Administration's decision to permit the General brand of the smokeless tobacco product snus to claim that it poses a "lower risk of mouth cancer

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
Before receiving breast implants

FDA May Put Strong Warning on Breast Implants

Agency suggests boxed warning, checklist outlining potential harms, such as pain, fatigue, further surgery