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...
What is new about PDUFA V? Congress, the media, and the public have a history of boiling down the issue to whether drugs are safe or not safe. In reality the issue is benefit versus risk. In addition, this judgement needs to be aligned with that of the patients...
The increased requirement for combined chronic toxicity and fertility assessment of biologics has led to greater use of sexually mature non-human primates. Older animals have different needs compared to the younger, adolescent animals with which we are used to...
