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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.

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its pharmacovigilance procedures guidance with new advice about periodic safety update reports (PSURs).

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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.

RAPS Convergence is where the world’s regulatory affairs community gathers to share expert insights and create meaningful connections. We’re talking to the speakers behind this year’s event to get the inside scoop on the topics everyone will be talking about and their tips for making the most of your week. Next up: Richard Holborow, head of clinical compliance at BSI.

The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) has issued a guidance to assist sponsors in assessing potency assays for active immunotherapy products (ACTIMPs), including cancer vaccines and treatments for autoimmune diseases.

The US Food and Drug Administration (FDA) recently sent warning letters to companies in China, India, and the US for multiple violations of good manufacturing practices (GMP) related to the production of active pharmaceutical ingredients (APIs) and finished drugs.

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

The US Food and Drug Administration (FDA) is seeking feedback on a competency-based approach to regulating medical devices that utilize generative artificial intelligence (GenAI).

The US Food and Drug Administration (FDA) on Monday finalized guidance on its approach to making therapeutic equivalence (TE) evaluations and assigning therapeutic equivalence (TE) codes for abbreviated new drug applications (ANDAs). These codes are listed in the agency’s Orange Book and denote a drug’s bioequivalence to a reference-listed drug (RLD).