Digital Technologies

Draft recommendation for investigators to maintain a task log of activities that local health care providers perform was removed from final guidance on decentralized clinical trials. Other changes include more detail on US FDA oversight and what HCPs can and cannot do in such studies.

The Australian teletrials program has surpassed expectations at its mid-way point and is being used by drug and device sponsors looking to enhance trial participant recruitment and retention by enabling access to rural, regional and remote areas.

The implementation phase of the European Health Data Space is an opportunity to address “critical aspects” of the new regulation that require clarification, says pharmaceutical industry federation EFPIA.

Europe’s Innovative Health Initiative, a public-private funding partnership, has put out a call for a research project that could help analyze the use of regulatory sandboxes in health care innovation in addition to three others.

In an interview with the Pink Sheet, Troy Tazbaz, director of the US FDA's Digital Health Center of Excellence, says the agency lacks authority to regulate assurance labs, which would be used to help AI developers ensure their models are working correctly before submitting them for approval.

Faster, more powerful and able to handle voices and visual images, newly released AI platform GPT-4o could potentially accelerate many tasks currently handled by pharma firms' medical affairs professionals, who are exploring ways to keep themselves relevant while embracing the unprecedented technology, DIA China hears.

Real-world data collected from a wide range of sources, such as wearable devices and public databases, can be used by pharmaceutical companies to boost their marketing authorization and health technology assessment applications, a regulatory policy expert from Sanofi says.

CDER Director Cavazzoni is promising to increase coordination and collaboration to accelerate broader adoption of innovative clinical trial designs and other approaches to speed drug development. A new "Quantitative Medicine Center of Excellence" illustrates the approach. 

The group will coordinate quantitative medicine issues throughout the FDA's Center for Drug Evaluation and Research to help streamline drug development.

European co-legislators have reached a compromise on the text of the European Health Data Space that will see the controversial opt-out mechanism included in the framework – but with some limitations.

The pharmaceutical industry has warned co-legislators against any hasty compromises that could impact the competitiveness of EU research.

During the first international symposium on the use of AI in medical products, co-hosted by US and Korean regulators, global experts discussed issues and challenges related to effective development and regulation. Cooperation, flexibility and the need for a "human-centric" approach emerged as key themes in the fast-moving field.

Some innovative cancer drugs are not reaching eligible patients in the UK, despite securing positive reimbursement opinions from NICE. Eli Lilly explains how industry can be “part of the solution” through partnership initiatives.

While EU preparations are underway to introduce strict legal requirements for all AI systems, the UK has doubled down on its flexible, non-regulatory framework. In this second of a two-part article, a lawyer explains the pros and cons of each for pharma and medtech firms.

While some progress has been made in strengthening the proposed European Health Data Space during legislative negotiations, further amendments must be made to protect trade secrets and avoid fragmentation, pharma industry federation EFPIA says.

Intellectual property conflicts, vague terminology, and excessive health data transfer requirements are among the problems with the proposed European Health Data Space highlighted in a new position paper by DIGITALEUROPE.

Speaking at the Consumer Electronics Show, FDA commissioner says agency and industry must work together to understand AI/ML and continuously assess the algorithms for efficacy.

With the EU’s AI Act set to enter into force early this year, a life sciences lawyer tells the Pink Sheet how pharmaceutical firms could be affected by the landmark legislation in areas such as clinical trial recruitment and drug dose personalization.

A report by the European Medicines Agency outlines the progress that has been made so far in delivering on the key pillars of its five-year network strategy, proposed in 2020, and lists areas where work is ongoing.

Multiple guidance documents, a regulatory sandbox, and the creation of an “observatory” to monitor the emergence of new technologies are some of the actions being considered by the European medicines regulatory network under its AI regulatory system workplan.