Search Results for QbD pilot

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EMA-FDA QbD Pilot Program Led to Further Harmonization By Zachary Brennan - Published 19 April 2017

The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have wrapped up a joint pilot program assessing applications containing Quality by Design (QbD) elements that led to further hamornization of concepts introduced through the International Council for Harmonisation (ICH).

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Manufacturing, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: QbD pilot, EMA-FDA joint program, quality by design

US, EU Regulators Extend QbD Pilot, Pledge Release of Further Quality Guidelines Published 06 March 2014

Categories: US, EMA, FDA

Tags: QbD Pilot Program, Quality-by-Design, Latest News, QBD, EU