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An Iran-linked hacker group called Handala Team has claimed responsibility for an attack that disrupted Michigan-based medical device manufacturer Stryker's Microsoft systems this week. While the company has said the damage from the incident is contained, a cybersecurity expert says it could lead the US Food and Drug Administration (FDA) to reassess its cybersecurity requirements.

The International Medical Device Regulators Forum (IMDRF) has published two new documents to help regulators and sponsors harmonize adverse event terminology and support regulatory reliance across regulatory agencies. The international group stated that regulatory reliance may help streamline activities by leveraging trusted regulatory authorities and that harmonizing adverse event terminology can help regulators detect safety signals sooner.

The survey also uncovered problems as respondents 'highlighted challenges such as the regulatory burden, access to finance and regulatory fees, calling for regulatory simplification and streamlining, access to funding and enhanced advice and support,” EMA noted.

The US Food and Drug Administration (FDA) has announced that six approved autologous chimeric antigen receptor T-cell (CAR-T) immunotherapies will no longer be required to comply with risk evaluation and mitigation strategies (REMS) reporting requirements. This decision is based on a better understanding of these products since their initial approval in 2017.

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released six guidelines to clarify expectations and support the new regulatory framework for decentralized manufacturing (DM), which takes effect on 23 July 2025.

Pharmaceutical industry groups say that more information and examples are necessary to effectively use various modeling techniques for drug development under the International Council for Harmonisation's (ICH) draft M15 guideline on model-informed drug development (MIDD).

The Pharmaceuticals and Medical Devices Agency (PMDA) has published details of the steps it is taking to promote the development of drugs for use in children in Japan.

The call for evidence provides more information on what the Commission wants to achieve and how. The goal is to provide a framework to strengthen equitable access to and supply of crisis-relevant MCMs while making the EU more competitive and innovative.

The United States Pharmacopeia (USP) has released its inaugural Vulnerable Medicines List (VML), which identifies 100 drugs that may be at risk of shortages. The list aims to help manufacturers, purchasing organizations, and policymakers recognize medications that have a higher risk for shortages so they can take appropriate action to before shortages occur.

PMDA has recently embarked on a push to engage with overseas companies, providing the help and resources they need to bring their products to market in Japan.

The US Food and Drug Administration (FDA) is exploring a new regulatory framework for human cells, tissues, and cellular and tissue products (HCT/Ps) in response to the growing variety and complexity of these products, which can no longer easily be categorized into broad classifications.

ICH M12 came into effect in November and superseded an EMA guideline on investigating drug interactions that had been in force since 2013. While M12 has replaced the EMA text, the new guideline does not cover some topics to the same extent as its predecessor because the ICH considered them out of scope.

The European Medicines Agency (EMA) has recently adopted a guideline outlining the quality, non-clinical, and clinical requirements to support a clinical trial application for investigational advanced therapy medicinal products (ATMPs).

The guidance, created with the Indian Council of Medical Research (ICMR), sets out 'a comprehensive framework to systematically evaluate and confirm the diagnostic performance of a given test, ensuring its reliability and its utility for clinical decision making,” according to the agencies.