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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 US Food and Drug Administration (FDA) has issued warning letters to several drugmakers for violations of current good manufacturing practices (CGMP). The agency also issued a warning letter to a Chinese drugmaker for marketing drugs in the US without providing regulators with the critical records needed to ensure compliance.

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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 Regulatory Reconnaissance, your regulatory news and intelligence briefing.

India has adopted legislation expanding the mandatory use of QR codes for tracing more drugs across the supply chain.

The World Health Organization (WHO) published a draft guidance this month that aims to assist regulators and pharmaceutical companies in integrating environmental sustainability strategies and metrics into pharmaceutical manufacturing.

European groups have raised questions about how patient preference studies (PPS) can be adapted from one region to another under the International Council on Harmonization (ICH) E22 guideline. Similar to their counterparts in the US, one major pharma group in the EU expressed the need for caregiver input for these studies. This feedback was in responses submitted by industry groups and manufacturers to the European Medicines Agency (EMA) during its call for comments on the guideline.

The US Food and Drug Administration (FDA) says two marketing videos submitted by Pinnacle Biologics make misleading statements about the company's cancer drug Photofrin (porfimer sodium), noting that the lack of details about the drug's full indication and limitations, especially insufficient statements about its risks, could mislead healthcare providers.

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.