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20 September 2019
This article discusses implementation of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR) regarding the potential exit (called Brexit) of the United Kingdom (UK) from the European Union (EU).

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20 September 2019
The US Food and Drug Administration (FDA) on Thursday opened a public consultation to gather input on the development and evaluation of abuse-deterrent formulations (ADF) of central nervous system (CNS) stimulants.
20 September 2019
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday recommended the approval of three new medicines, including one orphan product, and recommended extending the indication for eight other drugs.
20 September 2019
Notified body TÜV SÜD announced Thursday that it has issued the first Medical Devices Regulation (MDR) certificate for one of Germany-based Biotronik’s Class III (highest-risk category) medical devices, in addition to its quality management system.
19 September 2019
As part of work to implement the optional Safety and Performance Based Pathway for medical devices, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday issued four draft guidance documents iden...
19 September 2019
Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.
19 September 2019
A subcommittee of the House Energy & Commerce Committee held a hearing on Thursday raising questions around some of the tactics pharmaceutical companies use to block competition, including the controversial use of product hopping.