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...
Scientists at the Massachusetts Institute of Technology (MIT) and the University of Vienna have developed a light-field laser imaging system that generates 3D movies of entire brains at a millisecond timescale to create a complete “living” brain map. The research...
According to a commentary by former Institute of Medicine (IOM) committee members, published this week in the New England Journal of Medicine, increased “fast-tracking” of drug approvals (i.e., for medical conditions with no effective treatment)...
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 •...
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...
