Regulatory Focus

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published “review points” for medical devices using generative AI.

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, there are reports that some staff are concerned that a new HHS performance assessment could be a prelude to more layoffs, former FDA chiefs criticized last year’s mass firings, and more.

At some advisory committee meetings, more than half of patient and consumer representatives who attended had connections to organizations with these active ties to industry.

The US Food and Drug Administration (FDA) has issued warning letters to several drug manufacturers for failing to meet current good manufacturing practices (CGMP) requirements, and to a research laboratory for failing to comply with good laboratory practices (GLP). The specific issues include concerns about ensuring that final products are sterile and meet specifications, and, in the case of the research laboratory, that the final report adequately details the experience of its animal subjects.

A new initiative from the US Food and Drug Administration (FDA) aims to develop “an optimized, fit-for-purpose” framework to facilitate the development and marketing of treatments for rare diseases, according to a 14 October announcement from the agency.

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

Congress should enact a specific regulatory framework for artificial intelligence (AI) models developed and used in academic medical centers, Scott Gottlieb argued in an opinion piece published in JAMA Health Forum. Such systems should not be regulated as commercial medical devices or left unregulated, according to Gottlieb, a former Commissioner of Food and Drugs, now at the American Enterprise Institute. Three experts who spoke with Focus said they support the plan.