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

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

Supernus Pharmaceuticals has won US approval for its wearable pump Onapgo (apomorphine hydrochloride) to treat symptoms of ...

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

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

Tazbaz was director of the FDA’s Digital Health Center of Excellence for two years, leading key policies on artificial intelligence and software as a medical device.

Senseonics has filed to obtain CE Mark registration for its one-year continuous glucose monitoring (CGM) system, Eversense 365. The CE Mark submission aligns with the EU Medical Device Regulation (MDR ...

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 ...

New Partnership for Africa’s Development (AUDA-NEPAD) and the Africa Centres for Disease Control and Prevention (Africa CDC) ...

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

The Budget Estimates (BE) for the Centrally Sponsored Scheme of Strengthening of States Drug Regulatory System (SSDRS) for the fiscal year 2025-26 is Rs. 50 crore, around 33 per cent less than the ...