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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. This week HHS said several of former FDA Commissioner Marty Makary’s initiatives would continue to be implemented at the agency, the device center celebrated 50 years of the law that created the modern medtech regulatory framework, and more.

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.

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.

Planned changes to the Medical Device Regulation (MDR) would impose “invalid and unenforceable” fee requirements on notified bodies, according to a legal opinion shared by Team-NB.

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

The US Food and Drug Administration (FDA) has finalized a revised draft guidance from 2022 on what human factors (HF) information sponsors should include in premarket submissions for medical devices.

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.

The European Commission has published an analysis detailing the benefits of enacting the European Biotech Act, which was proposed last year as a means of increasing the EU’s competitiveness in the sector, in part by simplifying regulations.

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.

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