Regulatory Focus

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 Commission has published two delegated acts that expand the list of well-established technologies (WET) under the Medical Devices Regulation (MDR) that are exempt from conducting clinical investigations and technical assessments. The first regulation applies to implantable devices and Class III devices, while the second regulation focuses on Class IIb implantable devices.

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.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

Officials from the US Food and Drug Administration (FDA) and pharmaceutical industry representatives could not reach an agreement on the number of reference product exclusions (RPE) to make each year, and agreed to table the issue until another meeting, according to the minutes from a recent discussion on reauthorizing the Biosimilar User Fee Act (BsUFA).

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.