With the pharma and healthcare landscape increasingly being shaped by artificial intelligence (AI), the US Food and Drug Administration (FDA) has taken proactive steps to outline a comprehensive strategy for regulating AI in medical products.
The agency's requested funding for FY 2023, nearly 34% higher than for FY 2022, calls for investments in public health modernization and pandemic preparation.
Heads of state of seven African countries met in Lomé, Togo, to sign the Lomé Initiative, a political declaration to tackle fake medicine distribution on the continent.
Rho experts speak to the challenges facing drug development, meeting unmet needs, quality by design, and advances in technology, among other topics, during a sit-down at the CRO’s headquarters.
Regulatory actions by the FDA have enabled rare disease drug development to become a compelling space with orphan drug designations and approvals trending upward, says life sciences industry attorney.
Parexel and CluePoints to use CSM solutions for preclinical and clinical risk-based monitoring, after regulatory guidelines impact mutual acceptance of data across the US, EU and Japan.
Artificial intelligence advances threaten data privacy, according to a new study, which found it is possible to re-identify individuals using their physical activity data.
Global regulatory agencies had a busy 2018. Here, we take a look back at some of the key developments throughout the year, as the industry navigated challenging politics, pressure to increase transparency, and the rapidly evolving digital health space.
Moving forward, China will take a more integral role in global drug development, following several regulatory changes designed to accelerate innovation.
