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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. According to news reports, the Trump administration may create two more FDA executive positions in a possible bid to exert more control over the agency; FDA approved several first-of-its-kind treatments, including a drug that was approved well ahead of its decision date and a wearable device that tracks ketones and glucose levels.

The US Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) has issued an untitled letter to Alar Pharmaceuticals, accusing the company of making misleading claims regarding the safety and effectiveness of ALA-3000 (ketamine pamoate), its investigational new drug for treatment-resistant depression (TRD).

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).

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

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.

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

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.