Regulatory Blog

The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER)  has unveiled an innovative initiative—the CDER...

Recently the International Council for Harmonisation (ICH) announced on 24 May, 2024 the availability of draft guidance for the industry...

On 12 April 2024 the European Medicines Agency released "Guidance on real-world evidence provided by EMA: support for regulatory...

Recently (14 December 2023) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research Center for Devices...

Earlier today (08-September-2022) USFDA's Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research...

Real-World Data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of...

This guidance provides recommendations to sponsors for complying with section 745A(a) of the 30 FD&C Act (21 U.S.C. 379k-1(a)) when...

On 28-September, 2021 USFDA released the guidance “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To...