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A new draft guidance document quietly issued last week by the US Food and Drug Administration (FDA) is intended to explain how medical device manufacturers can show their devices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

FDA Guidance May Increase Number of Devices with Pediatric Labels and Indications

FDA has tried to tackle the dilemma of off-label use of medical devices in children by giving industry guidance on extrapolating adult clinical data to pediatric use. In early May, FDA released draft ...
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

CMS’s Final RADV Rule Announces No Extrapolation Methodology, No FFS Adjuster

The Centers for Medicare and Medicaid Services (CMS) issued a final rule on the use of extrapolation to determine overpayments in risk adjustment data validation (RADV) audits of Medicare Advantage ...
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 Develop Data-Derived Extrapolation ...