Ferdous Al-Faruque

The US Food and Drug Administration@s (FDA) Center for Drug Evaluation and Research (CDER) has launched a new center for internal and external experts to discuss new methods for designing and conducting clinical drug trials, dubbed the Center for Clinical Trail Innovation (C3TI).

The US Food and Drug Administration (FDA) has published a chemical dataset that analytical laboratories can use to demonstrate they can detect chemicals that may not be biocompatible for use in medical devices. The agency says the dataset is meant to help streamline the medical device biocompatibility testing and review processes.

The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) have released a new guideline outlining the steps involved for EU stakeholders, including national competent authorities, scientific committees, and other partners to request EMA conduct real-world evidence (RWE) studies to inform regulatory decision-making.

WASHINGTON @ According to Richard Phillips, executive director of the Association of British HealthTech Industries (ABHI), the UK@s Medicines and Healthcare products Regulatory Agency (MHRA) is preparing to deploy an international recognition framework for medical devices that would allow device makers to bring products to the UK more easily.

BERLIN @ Is regulatory affairs science or art? Experts considered that question as they kicked off the 2024 RAPS Euro Convergence conference plenary session on Monday, during which panelists presented various pieces of art and drew parallels between the art and their experiences in regulatory affairs.

BERLIN @ Experts and stakeholders involved in the discussions over the EU@s pharmaceutical legislation say they are in talks with key players to ensure the upcoming June parliamentary elections don@t disrupt its chances of being implemented.

Berlin @ Representatives of European regulators and health authorities offered assurances that the recent Artificial Intelligence Act (AI Act) is compatible with the Medical Device Regulation (MDR), that they are working to ensure product availability in the region, and other pressing topics during a panel discussion and Q@A at the 2024 RAPS Euro Convergence conference. @

BERLIN @ A panel of experts said stakeholders should focus on ensuring innovative and orphan devices get to market and keep digitalization in mind as they transition to the EU Medical Device Regulation (MDR). As stakeholders have gained experience with MDR, they said they need more clarity on product- and technical dossier-related guidance than on how the regulatory framework should work.

BERLIN @ Experts are concerned that the recently adopted European Artificial Intelligence (AI) Act is in some ways incompatible with the Medical Device Regulation (MDR), in part due to conflicting terminology across the two documents. @

As regulators grapple with supply chain issues and preventing drug shortages, one expert says he foresees European regulators requiring manufacturers to include supply chain information in their marketing applications that could delay approvals.