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A new draft guidance document quietly issued last week by the US Food and Drug Administration (FDA) is intended to explain how medical device manufacturers can show their devices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

Survival Extrapolation in Cost-Effectiveness Analysis

Survival extrapolation plays a pivotal role in cost-effectiveness analysis by extending observed clinical trial data to estimate long-term patient outcomes. Given that the follow‐up periods of trials ...
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 ...
RAPS

FDA Finalizes Guidance on Extrapolating Data for Pediatric Medical Devices

A little more than a year after introducing the draft version, the US Food and Drug Administration (FDA) on Monday finalized guidance on how and when it may be appropriate to leverage existing ...
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 ...