RAPS

Stakeholders request elaboration, consistency in FDA’s non-interventional RWE studies guidance

Reacting to new regulatory draft guidance on observational studies, stakeholders asked the US Food and Drug Administration (FDA) to flesh out its advice with examples and to ensure consistency with ...
RAPS

FDA issues draft guidance on study designs using real-world data

The US Food and Drug Administration (FDA) has issued draft guidance to industry on how real-world data (RWD) could be used in clinical trials and how it could be incorporated into the design of ...

FDA crackdown targets unpublished research results

A technician prepares for a genome sequencing experiment at the Cancer Genomics Research Laboratory. Photo: National Cancer ...
MedPage Today on MSN

FDA urges pharma to publish trial data, warns of 'distorted' evidence base

Publishing bias may over-represent successes and under-represent failures, agency says ...