Two US pharmaceutical industry groups note that they are generally supportive of the International Council for Harmonization (ICH) guideline on pediatric extrapolation in drug development but suggest ...
1. The government has been dramatically increasing the use of data mining to identify potential health care fraud and data analysis to support liability and damages in False Claims Act cases. 2. One ...
A new draft guidance document quietly issued last week by the US Food and Drug Administration (FDA) is intended to explain how medical device manufacturers can show their devices are safe for use in ...