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.

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.

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.

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the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday issued four draft guidance documents iden...

Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.

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.