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 ...

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

From the founders of BoldType comes CyberMed, a new company dedicated exclusively to MedTech cybersecurity. With a mission to ...

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

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 ...

Today, adoption of digital health faces some of the same barriers — scepticism, budget limitations, high expectations, and a ...

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed ...

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 ...

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

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

On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms ...