Intra-Class Comparisons Could Help Drugs With Safety Issues – FDA’s Temple
Executive Summary
Drugs with potential safety concerns could benefit from demonstrating an efficacy advantage over other agents in the same class, FDA Center for Drug Evaluation & Research Office of Medical Policy Director Robert Temple suggested June 28
You may also be interested in...
PPIs Get AHRQ Stamp Of Approval Vs. Surgery; Generics Could Be Big Winners
The Agency for Healthcare Research & Quality's study on the effectiveness of proton pump inhibitors could lead to more difficulties for brand companies in seeking formulary placement
PPIs Get AHRQ Stamp Of Approval Vs. Surgery; Generics Could Be Big Winners
The Agency for Healthcare Research & Quality's study on the effectiveness of proton pump inhibitors could lead to more difficulties for brand companies in seeking formulary placement
Hypertension Rx Labels Should Include Product-Specific CV Data – Cmte.
Data on antihypertensives that have shown cardiovascular endpoint benefits in well-controlled trials should be included in labeling, FDA and the Cardiovascular & Renal Drugs Advisory Committee agreed at a June 15 meeting