New FDA guidances aim to strike a balance by allowing firms to begin trials earlier through adaptive study designs, while ensuring that patients are adequately protected.
FDA released two draft guidance documents and announced a new pilot program last week in an attempt to make it easier for companies to begin clinical trials in the U.S.
The first draft guidance, issued Nov. 10, focuses on streamlining requirements to initiate and make changes to very-early-stage...
16 June marked the first major new regulatory instrument in the UK’s post-Brexit transition to a standalone device regulatory system for Great Britain.
With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.
Ahead of the 11 June UK spending review and its anticipated funding uplift for healthcare and life sciences, the MHRA announced an expansion of its digital expertise by creating a dedicated hub in Leeds, a renowned center of medtech excellence.
The EU’s Artificial Intelligence Act, which entered into force on 1 August 2024, is already facing turbulence.
