Ideally, every new drug would represent an unprecedented breakthrough and lead to the creation of a completely novel treatment. This, however, is not the reality of the pharmaceutical industry, or of any other development-based industry. Creating drugs based on...
In the FDA’s effort to make both its decisions and clinical trial data more transparent to the public, Agency decisions have become more available for public debate. Sophisticated analyses (increasingly by third parties) of publically available data may present...
In February 2010 the FDA published “Guidance for Industry on the Contents of a Complete Submission for the Evaluation of Proprietary Names” (Guidance), which describes in detail the FDA’s evaluation methodology for proposed proprietary drug names. By carefully...
Rare diseases can be described in terms of incidence, etiology, morbidity, and survival. Incidence can vary, however, from rare (e.g., Gaucher disease, cystic fibrosis) to epidemic proportions (e.g., HIV, malaria, cholera). The incidence of less frequently occurring...
In general, drugs often work in only half of the people who take them. In addition, billions are spent to treat adverse drug reactions and other complications. The personalized medicine approach is to elucidate the differences between patients who respond to a drug...
James N. Czaban (FDA Practice Group, Wiley Rein LLP) discusses trending topics of the FDA in regard to drug safety. panjiva ivermectin import pharmex A perception exists that the FDA does far more in terms of actual product testing and oversight than it is actually...
