Drug Safety Issues are Only Detected after Approval
In One-Third of Drugs, Safety Issues Identified after Approval A new study published in the Journal of the American Medical Association (JAMA) highlights the need for ongoing safety monitoring after drugs are approved and sold. Researchers found that, in about one-third of drugs approved by the U.S. Food and Drug Administration … [Read more...]
Drug Trials Involving Kids Need More Monitoring
Drug Trials Involving Kids Drug clinical trials involving children don't get enough scrutiny, a new study says. According to experts at Great Britain’s University of Nottingham, the method and processes in which drug trials are conducted in children require more and stricter monitoring and more needs to be done to ensure the … [Read more...]
Accutane Label, iPledge Monitoring Program Changes Approved by FDA
Accutane Label, iPledge Monitoring Program Since an Accutane lawsuit against Roche is not uncommon phenomenon in the US and other countries that suffered hugely from this drug, the manufacturer was ordered to make changes into the popular acne remedy’s labeling. The label for Accutane will be changed in an effort to improve the … [Read more...]
Inside The FDA
Two-Thirds Are Less Than Fully Confident In The FDA's Monitoring Of The Safety Of Prescription Drugs. About two-thirds of Food and Drug Administration scientists are less than fully confident in the agency's monitoring of the safety of prescription drugs now being sold, according to an FDA internal survey. As CBS News … [Read more...]
