RAPS

Study: Extrapolation used in more than half of pediatric drug labeling changes

Some form of data extrapolation – either full or partial – was used in making more than 63% of pediatric labeling changes in the United States between 2015 and 2021, according to a new analysis. The ...
RAPS

FDA Explains How to Extrapolate Data for Pediatric Medical Devices in New Guidance

A new draft guidance document quietly issued last week by the US Food and Drug Administration (FDA) is intended to explain how medical device manufacturers can show their devices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 ...
JD Supra

EPA Issues Guidance for Developing Data-Derived Extrapolation Factors

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 ...
The American Journal of Managed Care

An Overview of Biosimilar Extrapolation During FDA Approval

Specialists define and discuss extrapolation, along with the importance of strong data in specific disease states. This is a video synopsis/summary of a panel discussion involving Ryan Haumschild, ...
JD Supra

EPA Issues Guidance for Developing Data-Derived Extrapolation Factors

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 ...