The US agency has followed its public enthusiasm for increasing the use of real-world evidence to support pre-market and post-market device decisions with a draft guidance mapping out a strategy for doing so.
US FDA issued a draft guidance July 27 that the agency hopes will spur use of real-world evidence (RWE) and real-world data (RWD).
The guidelines, on how the agency plans to incorporate RWD into regulatory decision-making, comes as FDA has been championing the use of evidence sources such as registries to support pre-market and post-market device oversight. Meanwhile, the device industry
During his testimony before US senators on the impact of tariffs on critical supply chains, AdvaMed’s Scott Whitaker said the Trump tariffs could jeopardize America’s preeminence in medtech. Other industry experts echoed similar concerns.
In Vivo spoke to the previous commissioner of the US FDA about recent ongoings at the agency, and where he believes policy should be directed for patient and industry benefit.
The World Health Organization is seeking input from stakeholders to create an official definition of the term ‘diagnostics.’ This initiative follows a 2023 resolution aimed at enhancing global diagnostics capacity; the definition, it is hoped, will help drive the creation of effective health policies. Comments will be accepted until 23 May.
