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

Health Canada published a regulatory proposal in the Canada Gazette, Part I, Volume 158, Number 52, introducing amendments ...

In the EU, the AI Act has been approved, carrying significant implications for medical device, technology, and pharmaceutical firms. In the US, ...

In the United States, the biomedical industry encounters numerous regulatory challenges in conducting nonclinical and ...

Beta CEO Marcel Botha talks about the FDA’s plans for medical shortage notifications and how Trump’s policies may impact US ...

While experts across the political spectrum are generally in favor of stricter regulations ... FDA classifies most beauty products as low risk to health as compared to drugs and medical devices.

New documents clarify how the FDA plans to regulate AI-enabled devices, experts say, but several important questions remain ...

India's pharmaceutical industry is set for growth, driven by strong market players, global reputation, and evolving trends.

The Food and Drug Administration (FDA) is spearheading efforts to boost the local manufacturing industry by creating ...

In the final days of the Biden Administration, the United States Food and Drug Administration (FDA) issued final guidance on ...

The new director of the FDA’s device center contrasted a European rule with the lack of mandatory reporting requirements for ...