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Healthcare & Life Sciences

24 April 2019
Katie Lee Final regulations addressing public release of clinical information now in force

Canada - Smart & Biggar/Fetherstonhaugh

The final Regulations Amending the Food and Drug Regulations and Regulations Amending the Medical Devices Regulations recently came into force. Their objective is to provide public access to clinical information submitted to Health Canada for drugs for human use and medical device applications. As a result of the regulations, Health Canada published (among other things) a guidance document to help explain aspects of the new regulations, such as the procedures to prepare information for release.

Author: Katie Lee
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Robert J Conlan Jr Third Circuit finds individual ownership interest in corporation not required for False Claims Act liability

USA - Sidley Austin LLP

The Third Circuit recently affirmed and vacated in part a district court ruling granting the United States' motion for summary judgment. The case raised, among other things, the issue of whether an individual without any ownership interests in a company can face False Claims Act liability for the company's failure to perform a required act to qualify for reimbursement and whether an unsworn statement is sufficient to create a material issue of fact when weighed against facts admitted during a plea colloquy.

Authors: Robert J Conlan Jr, Kristen A Knapp
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Recent updates

Jaime L M Jones DOJ files complaint in intervention in Medicare Advantage case against Sutter Health

USA - Sidley Austin LLP

Authors: Jaime L M Jones, Jennifer M Haney
Andrew Mandlsohn Apotex seeks leave from Supreme Court of Canada in cefaclor damages action

Canada - Smart & Biggar/Fetherstonhaugh

Author: Andrew Mandlsohn
Constantinos Christofi General Healthcare System contributions

Cyprus - Elias Neocleous & Co LLC

Author: Constantinos Christofi
José Alberto Campos Vargas Ministry of Health announces new cannabis regulations

Mexico - Sanchez DeVanny Eseverri SC

Authors: José Alberto Campos Vargas, Juan Luis Serrano-Leets
Riccardo Fruscalzo Towards the adoption of national templates for CTAs

Italy - Hogan Lovells

Authors: Riccardo Fruscalzo, Carlotta Busani