Originally posted on Regulatory Focus – a RAPS publication The new EU Clinical Trials Regulation represents the most significant overhaul...
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Combination Drug Products– Regulatory Landscape Update
In 2016 we released a paper, “4 Things You Need to Know About Combination Drug Compliance.” This paper is still entirely relevant today, and we encourage you to download it,...
FDA Seeking to Enhance Manufacturing of Cell Therapy and Gene Therapy Products
More consistent and reliable production cell therapy and gene therapy processes are critical for advancing innovative treatments. While cell therapy and gene therapy...
Comprehensive Regenerative Medicine Policy Framework Announced by FDA
On November 16, 2017 the U.S. Food and Drug Administration announced a comprehensive policy framework for the development and oversight of regenerative medicine products,...
The FDA’s Groundbreaking Strides Toward a Quality-Centric Regulatory System
Two famous pharmaceutical industry quotes encapsulate industry thinking and the push for progress in recent years. Upon launching Pharmaceutical cGMPs for the 21st Century –...
