Joanne S. Eglovitch

The Pharmaceutical Research and Manufacturers of America (PhRMA) said the US Food and Drug Administration's (FDA) recent draft guidance on marketing exclusivity for new clinical investigations provides essential clarity on the types of applications that are eligible for the incentive. However, both PhRMA and Novartis highlighted that additional clarification is still necessary on some topics.

An official from the US Food and Drug Administration (FDA) on Monday presented three case studies demonstrating how sponsors effectively utilized real-world evidence (RWE) and real-world data (RWD) to secure approval for their products.

Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), reported that the agency has approved 17 pharmaceuticals that utilize continuous manufacturing in their production.

Pharmaceutical industry groups say they support the US Food and Drug Administration's (FDA) draft guidance on new approach methodologies (NAM), which aims to replace animal testing with innovative models, such as in silico modeling, to assess drug safety.

The US Food and Drug Administration (FDA) recently issued warning letters to drugmakers in Japan and the US, as well as a producer of active pharmaceutical ingredients (APIs) based in India, citing the firms for violations of current good manufacturing practice (cGMP). Additionally, the agency warned a clinical investigator for informed consent, participant screening, and other issues related to the conduct of a clinical trial.

A recent survey published by Team-NB reveals that the growth of certificates for the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) slowed in 2025 compared to previous years. Additionally, the staffing levels for notified bodies (NB) have decreased due to a reduction in workload.

Most manufacturers of medical devices with artificial intelligence (AI) features are not using predetermined change control plans (PCCPs) to manage changes throughout the device's lifecycle, representing a "missed opportunity" to improve device performance, according to a recent research letter published in JAMA Health Forum.

The US Food and Drug Administration (FDA) finalized two guidances on studies on 28 May to assist sponsors in establishing bioequivalence (BE) for new and generic drugs. One focuses on BE studies with pharmacokinetic (PK) endpoints, and the other on statistical methods for analyzing these studies.

Draft guidelines from the European Commission aim to assist companies in determining whether their products, including medical devices that incorporate artificial intelligence (AI) components, are classified as high-risk under the EU's Artificial Intelligence Act.

The European Commission has adopted a roadmap to phase out the use of animals in chemical safety assessments, including for pharmaceuticals.