Regulatory Focus

The Pharmaceuticals and Medical Devices Agency (PMDA) published guidance on using a weight of evidence (WOE) approach to assessing the toxicity of monoclonal antibodies in Japan.

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

Industry groups have asked the US Food and Drug Administration (FDA) to provide more clarity about its regulatory approach to digital health technologies (DHTs), as well as for greater flexibility in their use in clinical trials.

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, the Trump administration is reviewing candidates for FDA commissioner, the agency is trying to repair relations with the rare disease community, and Vanda will have an opportunity to defend its jet lag drug at a public hearing next month.

The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) sent an untitled letter to QOL Medical to “false or misleading” claims made in promotional emails for its congenital sucrase-isomaltase deficiency (CSID) treatment Sucraid (sacrosidase) oral solution.

During a public hearing on Thursday, the US Food and Drug Administration (FDA) received several suggestions from industry stakeholders on how to improve its Commissioner’s National Priority Voucher (CNPV) pilot program, though several observers were critical of the initiative.

The US Food and Drug Administration (FDA) recently sent warning letters to two facilities in the United States and Mexico for failing to comply with current good manufacturing practices (cGMPs) related to contamination issues and data integrity problems. The agency also warned a company in Brazil for failing to respond to a request for written records and to a laboratory in the US for nonclinical study violations.

MedTech Europe has voiced broad support for proposed changes to the In Vitro Diagnostic Regulation (IVDR), welcoming many proposals and pushing for the strengthening of some revisions.