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Focus on Regulation

Tag Archives: application

European Commission publishes new documents regarding the Clinical Trials Regulation

1.            Introduction Shortly after updating the related draft Questions and Answers document (see our blog), the European Commission has published two new documents concerning the Clinical Trials Regulation (EU) 536/2014. The first document is an informed consent and patient recruitment procedure template. The second document is an updated clinical trial Application Form.

California AG Sends Enforcement Letter to Developers of Popular Mobile Apps

On Tuesday, October 30, the Office of California Attorney General Kamala Harris issued a press release confirming that it had begun “formally notifying” mobile device application (“app”) operators that they are out of compliance with the notice provisions of the California Online Privacy Protection Act of 2003 (“CalOPPA”).  Those companies — many of which are major marketers — now