News & Insights Search

The US Food and Drug Administration (FDA) on Friday issued draft guidance to assist sponsors in providing necessary information for developing container closure systems and device constituent parts for biosimilar and interchangeable biosimilar combination products, such as prefilled syringes and autoinjectable pens.

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

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 This week, biostatistics experts took to JAMA to discuss the benefits and potential pitfalls of FDA’s recent draft guidance on Bayesian methods, FDA published a report on its GDUFA science program, and the agency released its OMUFA facility fee rates for FY 2026.

Groups representing drugmakers and combination product manufacturers have asked the US Food and Drug Administration (FDA) for more clarity on its recently published draft guidance on the use of cross-center master files (MF). More specifically, they asked how the agency will address master file deficiencies, communication between product centers and sponsors, center responsibilities, and more.

BRUSSELS – The European Commission's proposed revisions to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) include specific changes to the regulation of medical device software, including medical device artificial intelligence (AI), in Europe. According to experts who spoke at the 2026 DIA-RAPS Combination Products in the EU conference, the proposed changes would clarify how the products are classified and could delay the implementation of the EU Artificial Intelligence (AI) Act.

Medical device makers must comply with the US Food and Drug Administration's (FDA) Quality Management System Regulation (QMSR) after the rule took effect on Monday. Additionally, FDA inspections of device facilities will no longer be conducted under the prior Quality System Inspection Technique (QSIT) and instead will be carried out in accordance with a new compliance program manual.