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27 Mar 2026

This Week at FDA: Reactions to FDA’s Bayesian methods guidance, GDUFA science report, and more

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 This week, biostatistics experts took to JAMA to discuss the benefits and potential pitfalls of FDA’s recent draft guidance on Bayesian methods, FDA published a report on its GDUFA science program, and the agency released its OMUFA facility fee rates for FY 2026.

This Week at FDA
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06 Mar 2026

Journal of Regulatory Affairs: March-April 2026

Welcome to the Journal of Regulatory Affairs, featuring in-depth coverage of the EU Artificial Intelligence Act (EU AI Act) as well as articles on engineering safety and effectiveness in drug-device combination products and regulatory considerations for pharmaceutical excipient selection. These articles are exemplary of the mission of this new journal. They provide readers with valuable, evidence-based information on emerging issues in global healthcare regulation that can be used as guidance or a reliable resource in their daily regulatory work. They also flag the importance of companies, agencies, and professionals ensuring they are future-ready.

Journal
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06 Mar 2026

Regulatory considerations for pharmaceutical excipient selection

This article discusses the role and importance of excipients in medicines, focusing on regulatory aspects crucial for pharmaceutical companies. The aim of the article is to provide an overview of regulatory considerations in excipient selection and management, elucidating the complex landscape companies must navigate.

Journal
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25 Feb 2026

Combo products, drug industry groups seek more clarity about cross-center master file guidance

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product manufacturers have asked the US Food and Drug Administration (FDA) for more clarity on its recently published draft guidance on the use of cross-center master files (MF).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.

Regulatory News
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03 Feb 2026

EU Commission MDR/IVDR includes changes to medical device software classification, AI Act delay

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.

Regulatory News
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02 Feb 2026

QMSR is Live: Expert says new rule may be challenging for smaller firms, combination product makers

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.

Regulatory News
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15 Dec 2025

Companion diagnostics: Best practices for effective collaboration

The successful development and deployment of companion diagnostics (CDx) requires effective interactions between four different parties: the therapeutic developer, the diagnostic manufacturer, the drug regulatory body, and the diagnostic regulatory body. Ensuring effective collaboration requires that the parties understand each other's roles, responsibilities, and goals. This article highlights therapeutic, diagnostic, and regulatory perspectives of CDx and emphasizes the importance of open and transparent communication to support successful collaboration and patient access to these critical therapeutic tools.

RF Quarterly
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15 Dec 2025

RF Quarterly, December 2025: RAPS Convergence

Welcome to the December issue of RF Quarterly, featuring a selection of articles adapted from presentations at the 2025 RAPS Convergence in Pittsburgh, PA, on 7-9 October. The articles cover global regulatory pathways for orphan medical devices, best practices for effective collaboration around companion diagnostics, e-labeling in drugs and medical devices, and artificial intelligence (AI) in the regulatory setting – specifically, the use of generative AI (gen AI) for scaling up regulatory operations , and survey findings on how regulatory functions are adopting AI

RF Quarterly
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