Companies developing mobile health apps have a host of federal agencies they need to mind beyond just FDA, industry experts say. Firms should set up a team of experts to identify regulatory issues early in the development of such apps.
Companies developing mobile health applications should have a strong understanding of the roles of the various government agencies that may oversee their product and have a good team of people who understand the regulatory framework that could apply to their app according to industry experts.
Speaking at the annual Drug Information Association conference in Washington D.C
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.
