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...
Analysis and overview of new drug reviews from 1993 through present by an over 20-year-active FDA veteran of drug approvals, Dr. John Jenkins (Director, Office of New Drugs, Center for Drug Evaluation and Research). The presentation includes review times and...
In the next 2-5 years, large pharmaceutical companies plan to increase outsourcing of preclinical work, with emphasis on Discovery and non-GLP Toxicology. This trend is driven by the reductions in internal preclinical capability within Big Pharma. In an apparent...
Growth in demand for nonclinical toxicology services will be weak for the foreseeable future analysts said after the Society of Toxicology (SOT) annual meeting in San Francisco this past week. “Most agree that the industry is not merely going through a prolonged...
With the rise of combination therapy – the use drugs with different mechanisms of action to combat a specific disease state – comes the need to address medical costs and reimbursement issues. Joint negotiation of package deals with government and health...
For pharmaceutical companies, is personalized medicine more of a threat than an opportunity? In addition to the development of new drugs, genetic information can also help target the use of current medications (e.g., Plavix). The use of genetic (or other)...
