FDA Policy/General

FDA Launches New Neuroscience Program to Target Alzheimer's

FDA has launched a new cross-center program to advance medical product development for neurological and psychiatric conditions, with an initial initiative focused on improving clinical trial approaches for preventing or delaying Alzheimer's disease.

The Neuroscience Advancement and Innovation Nexus (NAIN) it intended to coordinate scientific and regulatory expertise across CDER, CBER and CDRH, according to the agency. It will seek to address regulatory science challenges involving drugs, biologics and devices for conditions affecting the brain and nervous system, including neurological and psychiatric disorders, substance use disorders and pain.

NAIN's first initiative, the Alzheimer's Prevention Accelerator, will explore new approaches to Alzheimer's clinical trials. FDA said the effort will emphasize selecting appropriate trial populations, developing endpoints suited to different disease stages, and establishing evidentiary approaches for demonstrating prevention or delayed cognitive decline.

FDA said neuroscience product development presents particular regulatory challenges because of incomplete understanding of disease biology, variable clinical presentations and difficulties demonstrating meaningful benefits in diseases that may progress over decades. Advances in biomarkers, digital health technologies and other development tools could help address those limitations, it said.

FDA Steps Up Form FDA-483 Disclosures ; 26 Records Posted

FDA has accelerated the public release of Form FDA-483 inspection records as part of its expanded transparency initiative (see earlier story), increasing the volume of inspection documents available through the agency's FOIA Electronic Reading Room. On 10/23, the agency published 26 Form FDA-483 records covering

Petition Seeks Immune Monitoring Requirements for Vertex's Povetacicept

A citizen petition filed by Foley & Lardner urges FDA to require mandatory monthly immunoglobulin monitoring and explicit treatment-interruption instructions in the prescribing information for Vertex Pharmaceuticals' investigational IgA nephropathy treatment povetacicept, ahead of an 11/30 user fee review action target date. The 10/21 petition contends

Patient Dies Following BMS Cell Therapy in Multiple Sclerosis Trial

Bristol Myers Squibb reported preliminary safety and efficacy data from a Phase 1 study of its investigational CAR T-cell therapy zolacabtagene autoleucel (zola-cel; BMS-986353) in patients with multiple sclerosis, but disclosed that one trial participant died of septic pneumonia 44 days after receiving treatment. The death reportedly

Congressional Gains Unlikely to Halt Vaccine Policy Changes: Analysts

If vaccine advocates gain substantial support in Congress following next month’s midterm elections, the Trump administration could still accelerate changes to federal vaccine policies in 2027, potentially limiting the effectiveness of congressional oversight, two former federal health policy officials warn. In a 10/20 MedPage Today commentary, Steven Grossman,

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FDA Steps Up Form FDA-483 Disclosures ; 26 Records Posted

Petition Seeks Immune Monitoring Requirements for Vertex's Povetacicept

Patient Dies Following BMS Cell Therapy in Multiple Sclerosis Trial

Congressional Gains Unlikely to Halt Vaccine Policy Changes: Analysts