Tracking Drug Manufacturing Plant Inspection Reports Online

Health Canada has put all Drug Establishment License (DEL) holders on alert as to their regulatory responsibilities and obligations for maintaining good manufacturing practices (GMP).  In addition to increasing the frequency of planned and unplanned inspections of...

CDER Guidances for Nonclinical Toxicology to Issue in 2012

The FDA has published an updated Guidance Agenda – new and revised draft guidances CDER is planning to publish during calendar year 2012.   Guidances of particular interest to nonclinical pharmaceutical toxicologists may include: Pharmacology/Toxicology •...

Off-label Drug Use: Fact vs. Fiction

The authors – CM Wittich, CM Burkle, and WL Lanier – offer a concise review of the topic of off-label drug use including its definition, prevalence, and implications for drug safety.   The article format addresses 10 common questions and their answers...

FDA Uses Linguamatics to Increase Drug Safety

Linguamatics, the leader in natural language processing (NLP)-based text mining, announced that the Federal Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has licensed its 12E text mining platform as a discovery and decision support...

New Procedure Cage Reduces Primate stress

An innovative Procedure Cage invented by Dr. Ryoichi Nagata, SNBL USA chairman, is at the center of a comprehensive program designed to significantly raise standards for non-human primate (NHP) care and thereby improve the quality of preclinical data collected. The...