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Drug manufacturing process models represent a "growing area" of scientific development and are increasingly being utilized in new drug applications (NDAs), biologics license applications (BLAs), and supplements to these applications, according to a recent review by US Food and Drug Administration (FDA) officials.

Pharmaceutical industry groups argue that the US Food and Drug Administration (FDA) should provide clearer guidance on the role of qualified research institutions (QRIs) in its proposed expedited investigational new drug pilot program, which is intended to reduce the time it takes to get drug candidates into first-in-human (FIH) trials.

The US Food and Drug Administration (FDA) on Friday outlined a set of proposed reforms to advance modern manufacturing methods and increase supply chain visibility. In a proposed rule, the agency said it will enable distributed manufacturers to register as a single entity under a “hub-and-spoke” model and clarified when foreign establishments must register as a manufacturer.

The US Food and Drug Administration (FDA) is seeking comments on a pilot program where qualified external institutions will collaborate with sponsors to develop and review protocols for first-in-human (FIH) clinical trials intended for investigational new drug (IND) submissions to FDA.

PHILADELPHIA – Officials from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) said that increased international collaboration is influencing the development of policies about artificial intelligence during the Drug Information Association's (DIA) Global Annual Meeting last week.

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.

LISBON – Orphan medical device makers should be deliberate in their questions to expert panels and ensure their post-market clinical follow-up (PMCF) plan is realistic, according to experts who spoke at RAPS Euro Convergence 2026 on Thursday.

The US pharmaceutical industry expressed support for the US Food and Drug Administration’s (FDA) proposed framework for increasing access to treatments for ultra-rare diseases yet raised questions concerning various aspects of the program.