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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. The US Food and Drug Administration (FDA) made several announcements related to its new drug voucher program, highlighted efforts to reduce animal testing, 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, FDA issued new guidance on organic impurities in antibiotics and sent a letter to combination product makers alerting them to potential nitrosamine impurities in products with a drug constituent.

The International Medical Device Regulators Forum (IMDRF) has released a draft technical document to create a harmonized set of best practices in mitigating risks associated with the use of artificial intelligence (AI)-enabled medical devices throughout their product life cycle.

Under EU law, active pharmaceutical ingredients (APIs) shipped from India and other non-listed countries must be supported by a written confirmation certificate stating the product meets good manufacturing practices.

The European Medicines Agency (EMA) has provided guidance to help manufacturers adhere to good manufacturing practices (GMPs) when using three-dimensional (3D) printing technology, also known as additive manufacturing, in the production of solid oral dosage forms.

Industry groups and drugmakers want the US Food and Drug Administration (FDA) to explicitly clarify that Bayesian statistical methods can be used for products beyond those intended for children and rare diseases. They also asked for additional case examples in the guidance to clarify the agency's expectations.

This article is the second of two on the EU Artificial Intelligence Act (EU AI Act) and its interaction with the EU Medical Devices Regulation (EU MDR) for AI‑enabled medical devices. The first article focuses on risk classification and the points of convergence and divergence between the two frameworks. Building on that foundation, this article identifies key implementation gaps and proposes ways manufacturers can operationalize EU AI Act obligations using existing EU MDR processes and international standards, including risk management, data governance, transparency, and postmarket monitoring, until CEN-CENELEC harmonized standards and common specifications become available. The article also provides a decision tree to help readers prepare for the phased rollout of EU AI Act implementation.