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Industry groups have asked the US Food and Drug Administration (FDA) to provide more clarity about its regulatory approach to digital health technologies (DHTs), as well as for greater flexibility in their use in clinical trials.

The US Food and Drug Administration (FDA) has proposed guidance on the types of scientifically valid prior knowledge sponsors should consider when developing certain gene therapies (GT). The agency said the recommendations in the guidance are intended to improve review efficiency and help accelerate product development.

The US Food and Drug Administration (FDA) has proposed guidance to reduce the need for animal testing in the development of oncology drugs as part of its broader efforts to reduce animal testing in drug development.

More flexibility in early-phase development for cell therapies is needed, a panel of US Food and Drug Administration (FDA) representatives and industry members said at a public meeting hosted by Friends of Cancer Research and the Parker Institute for Cancer Immunotherapy.

Planned changes to the Medical Device Regulation (MDR) would impose “invalid and unenforceable” fee requirements on notified bodies, according to a legal opinion shared by Team-NB.

The European Medicines Agency (EMA), in partnership with the European Commission (EC) and the Heads of Medicines Agencies (HMA), has published the first quarterly report on the state of clinical trials conducted in the EU and the European Economic Area (EEA). The report is intended to shed light on the progress being made to attract more clinical trials to the region and increase access to new treatments as part of the targets set by the EU in 2025.

An official from the US Food and Drug Administration (FDA) on Monday presented three case studies demonstrating how sponsors effectively utilized real-world evidence (RWE) and real-world data (RWD) to secure approval for their products.

The US Food and Drug Administration (FDA) has issued warning letters to two researchers for failing to meet good clinical practice (GCP) requirements and for not complying with their own trial protocols. The agency also cited several drug manufacturers for failing to adhere to current good manufacturing practices (CGMP).

New clinical trial regulations came into force in the UK this week, marking the biggest change in the law on running human studies in the country in more than 20 years.

WHITE OAK, MD – The US Food and Drug Administration (FDA) has announced plans for a future pilot program intended to facilitate the real-time review of clinical trials by regulators, as well as the launch of two proof-of-concept studies that will gather and report endpoints and other signals to regulators in real time.