Approval via Extrapolation and New Drugs: 6 Clinical Trials in Oncology and Neurology

From October 10 to October 16, we covered 6 items: 4 in oncology and 2 in neurology. The list features drugs with novel ...
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 ...
JD Supra

How OIG Used Data Analytics and Extrapolation in a $12.4 Million Hospital Audit

The HHS Office of Inspector General’s (“OIG”) September 2026 audit of Methodist Hospital located in San Antonio, Texas (“Hospital”) shows how a relatively small claim review can lead to a much larger ...
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

ICH E11A: Pharma groups want more information on data extrapolation, pediatric biomarkers

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 ...
Medical Xpress

Use of extrapolation common in FDA new drug approvals

Extrapolation from pivotal trial data to broader U.S. Food and Drug Administration (FDA)-approved indications is common, according to a study published online April 19 in JAMA Network Open. Daniel ...
TES

Interpolation and Extrapolation Graphing Worksheet with Data Interpretation

Interpolation and Extrapolation Graphing Worksheet with Data Interpretation Help students build confidence with interpolation, extrapolation, and graph interpretation through this structured lesson ...