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

Robert F. Kennedy Jr. vows to finalize regulations for greater diverse patient involvement in clinical trials during his ...

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

The U.S. Food and Drug Administration has pulled draft guidance from its website requiring companies to test medicines and ...

Health Canada published proposed amendments to the Food and Drug Regulations and Medical Devices Regulations to ...

February is observed as American Heart Month, a period dedicated to raising awareness about heart health. The first American Heart ...

While medical device shortages are nothing new, the FDA said it is becoming more concerned that supply chain disruptions are ...

The pathway allows medicine developers to work with the regulators, the NHS and health technology assessment bodies.

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

Dr. Sara Brenner, who has been FDA CDRH's in vitro diagnostics chief medical officer, is serving as acting commissioner of ...