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Industry and academic stakeholders have asked the US Food and Drug Administration (FDA) to clarify its objectives and plans for a proposed pilot program to evaluate how artificial intelligence (AI) technologies can help improve early-phase clinical trials. They also said the agency should develop a governance structure with specific metrics and goals and consider aligning its thinking with other regulators.

The European Medicines Agency (EMA) has published a concept paper to update its guidelines on developing antifungal drugs to treat and prevent invasive fungal disease (IFD). The guideline has been updated 17 times since the Committee for Medicinal Products for Human Use (CHMP) first adopted it in 2003, but regulators argue it should be updated again to reflect the latest scientific consensus and regulatory thinking.

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week HHS proposed several big measures to accelerate drug development, FDA warned about third-party testing facilities falsifying drug data, and the agency published several reports on the state of the drug industry and clinical trials.

The US Food and Drug Administration (FDA) roadmap to reduce animal testing as a requirement for drug development has already made an impact after its first year, but the initiative faces future challenges in scaling and international harmonization, a group of experts wrote in a recent paper published in Stem Cell Research & Therapy.

The US Food and Drug Administration (FDA) has revised a 2023 draft guidance on master protocols for drug and biological product development, reflecting significant stakeholder feedback it has received since the original draft was proposed. Among the updates is  a new section on evaluating drug effects across multiple diseases, conditions, or disease subtypes in basket trials.

As cell and gene therapies (CGTs) continue to advance, they have unique developmental features that may require innovation in a clinical trial setting, the authors of a recent paper explained.

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.