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Three major pharmaceutical industry groups—two in the US and one in India—have called for changes to the US Food and Drug Administration's (FDA) Scale-Up and Post-Approval Changes (SUPAC) guidelines. They believe these guidelines should be updated to reflect more modern manufacturing methods and better align with International Council for Harmonisation (ICH) standards.

Patients with breast cancer said faster approval times for oncology products, as a trade-off for evidentiary certainty, is most permissible in situations where there are no treatment alternatives, the results from a recent qualitative study suggest.

BALTIMORE – Kerri DiPietro, chief quality officer at Integra LifeSciences, said that drug and device makers need to be methodical and purposeful when considering elevating their companies' quality cultures. She noted that it involves getting buy-in from key leadership, measuring the progress, and implementing a plan that may take years to accomplish.

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The International Council for Harmonisation (ICH) has announced the adoption of Annex 2 to the guideline on Good Clinical Practices (GCPs) E6(R3). This annex focuses on the collection of data from a wider range of sources for clinical trials, including decentralized trials and pragmatic clinical trials (PCTs).

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.