MDR Certification Strengthens Resyca’s Leadership in Soft Mist Drug-Device Combination Products ENSCHEDE, NL / ACCESS Newswire / ...

Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...

Gottlieb, who led the agency during the first Trump presidency, supports a reversion to an earlier interpretation of the 21st Century Cures Act.

New Delhi: The Union government is drawing up an index to gauge states and union territories on their preparedness to enforce ...

FDA Medical Device Regulation Over the Use of AI in Clinical Trials As FDA noted in the JAMA article, artificial intelligence and machine learning (AI/ML) have many potential uses in clinical ...

Following a recall of grounding pads produced by Megadyne, a machinery industry company, the FDA is notifying veterinarians ...

Tazbaz was director of the FDA’s Digital Health Center of Excellence for two years, leading on policies involving artificial ...

The agency has not yet updated the Center for Devices and Radiological Health’s directory to reflect Tazbaz’s departure. During his tenure, the FDA created a new regulatory framework for updates to ...

MDR Certification Strengthens Resyca's Leadership in Soft Mist Drug-Device Combination Products ENSCHEDE, NL / ACCESS Newswire / January 28, 2025 / Resyca BV, a pioneering leader in the development an ...

In the United States, the biomedical industry encounters numerous regulatory challenges in conducting nonclinical and clinical studies and managing chemistry, manufacturing, and controls (CMC) ...

African National regulatory agencies (NRAs) under the World Health Organisation’s (WHO) maturity level 3, have signed a ...

As AI in the medical device space rises, it likely means 2025 will be another challenging year for cyber threats in healthcare.