Gottlieb, who led the agency during the first Trump presidency, supports a reversion to an earlier interpretation of the 21st Century Cures Act.
Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...
New Delhi: The Union government is drawing up an index to gauge states and union territories on their preparedness to enforce ...
Today, adoption of digital health faces some of the same barriers — scepticism, budget limitations, high expectations, and a ...
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 ...
From the founders of BoldType comes CyberMed, a new company dedicated exclusively to MedTech cybersecurity. With a mission to ...
The US Food and Drug Administration (FDA) rejected three prior regulatory applications before granting approval.
In the EU, the AI Act has been approved, carrying significant implications for medical device, technology, and pharmaceutical firms. In the US, ...
What will the industry face or achieve in 2025? These trends will be critical in medical device cybersecurity.
Britannia retains rights to its drug outside of the U.S. Onapgo, a device secured to the body by an elastic band worn around the waist, has had a rocky regulatory journey leading up to its FDA nod.
The pathway allows medicine developers to work with the regulators, the NHS and health technology assessment bodies.