The Food and Drug Administration issued a final guidance on Monday for how and when existing clinical data should be used to support pediatric medical device indications and labeling. The guidance ...

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 ...

The U.S. Environmental Protection Agency (EPA) announced on October 3, 2014, the availability of a final document entitled Guidance for Applying Quantitative Data to Develop Data-Derived Extrapolation ...

Drug developers face unique challenges in pediatric rare disease trials, including small and geographically dispersed patient populations, strict ethical limits on sampling and sparse early clinical ...