On 29 October 2026, the U.S. Food and Drug Administration (FDA) published a revised draft guidance, Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biological Products. The guidance replaces a 2024 draft and provides recommendations for identifying, verifying, validating, and controlling device characteristics essential to reliable drug delivery.

On 28 October 2026, the U.S. Food and Drug Administration (FDA) issued a draft guidance on the electronic submission of Investigational Device Exemption (IDE) applications. The guidance outlines proposed requirements for using the electronic Submission Template And Resource (eSTAR) to standardize IDE submissions and improve regulatory review efficiency. Once finalized, the requirements would become mandatory for specified IDE submissions following a transition period of at le

On 19 October 2026, the European Medicines Agency (EMA) launched a public consultation on its draft Reflection Paper on Methodological Aspects in Confirmatory Platform Trials. The document examines methodological considerations for designing platform trials that can generate reliable and interpretable evidence to support regulatory decision-making, including marketing authorisation applications.

On 19 October 2026, the European Medicines Agency (EMA) launched a public consultation on a draft chapter of the Data Quality Framework (DQF) for EU medicines regulation. The draft focuses on the collection, management and submission of adverse drug reaction (ADR) reports and aims to support more reliable pharmacovigilance activities and regulatory decision-making across both human and veterinary medicines.

On 25 September 2026, the U.S. Food and Drug Administration (FDA) issued draft guidance on Robotically-Assisted Surgical Devices – Premarket Submissions. The draft provides recommendations on premarket submission content, non-clinical testing, clinical evidence and labeling for certain robotically-assisted surgical devices (RASDs). It is intended to promote greater consistency in the information provided to FDA and facilitate the review of these complex systems.

On 18 September 2026, the U.S. Food and Drug Administration (FDA) issued draft guidance on the Electronic Submission Template for Premarket Approval Applications (PMAs). The draft describes FDA’s proposed approach to the electronic submission of specified PMA application and supplement types using the electronic Submission Template And Resource (eSTAR).

On 22 September 2026, the Medicines and Healthcare products Regulatory Agency (MHRA), together with the Regulatory Innovation Office (RIO), opened a call for evidence on the use and development of artificial intelligence (AI)-based approaches for medicines safety evaluation. The survey seeks information on current and planned uses of AI, as well as barriers and challenges relating to model development, validation, data access, data sharing and regulatory considerations.