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Focus On Regulation

Insights, analysis, and news about regulatory issues affecting a broad array of industries.

Blog Post

The Crackdown Continues: FDA Takes Action Against Company And Its Autologous Stem Cell Product, Alleging Significant Safety Concerns

05 January 18

Yesterday, FDA published a January 3, 2018 Warning Letter issued to American CryoStem for marketing Atcell—an adipose tissue derived stem cell product—without FDA approval and...

Blog Post

EMA provides essential considerations to be taken into account for successful qualification of novel methodologies

18 December 17

The European Medicines Agency (“EMA”) has published a checklist of the essential considerations to be addressed for successful qualification of novel methodologies.

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