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The European Medicines Agency (EMA) has published a guideline on evaluating drug interactions in the gastrointestinal tract that addresses situations in which extrinsic factors in the gastrointestinal tract may affect drug absorption.

CHARLOTTE, NC — Experts in medical device and pharmaceutical regulatory affairs discussed how the field has evolved over the last five decades and how professionals can continue to face the challenges that come their way during the opening plenary session of RAPS Convergence 2026.

CHARLOTTE, NC — A panel of experts representing the European Commission, industry, and notified bodies reviewed the state discussed the current state of play amid proposed reforms to the EU Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) at RAPS Convergence 2026.

CHARLOTTE, NC — Officials from the European Commission and European Medicines Agency (EMA) touted key reforms presented in the proposal to overhaul the bloc’s pharmaceutical legislative framework during a panel discussion at RAPS Convergence 2026.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has adopted a multi-year strategy aimed at ensuring continued patient-centered regulation in the era of emerging artificial intelligence (AI) and personalized medicine. The plan outlines commitments and steps the agency should take through 2030 to keep pace with rapid technological and scientific developments and bring safe and effective treatments to patients more quickly.

The US Food and Drug Administration (FDA) has issued warning letters to several drug manufacturers for failing to meet current good manufacturing practices (CGMP) requirements, and to a research laboratory for failing to comply with good laboratory practices (GLP). The specific issues include concerns about ensuring that final products are sterile and meet specifications, and, in the case of the research laboratory, that the final report adequately details the experience of its animal subjects.

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we're reading from around the web. This week, there are reports that some staff are concerned that a new HHS performance assessment could be a prelude to more layoffs, former FDA chiefs criticized last year's mass firings, and more.

BOSTON – Despite some early jitters, the medtech industry is coming around to the Quality Management System Regulation (QMSR), according to a top industry executive who spoke at The MedTech Conference on Monday.

BOSTON – Top US Food and Drug Administration (FDA) medical device officials said they are focused on restaffing after last year's reduction-in-force (RIF) and are optimistic about the Medical Device User Fee Amendments (MDUFA VI) agreement during a town hall panel at The MedTech Conference.

BOSTON – There needs to be a cultural shift to foster trust between regulators and the medtech industry when developing real-world evidence (RWE) to support the marketing of medical devices, according to experts who spoke at The MedTech Conference on Monday. They also noted that developing standards is key to expanding the use of RWE.