FDA

HHS announced an FDA guidance and expanded CMS payment model to help patients with rare genetic diseases.

The initiative will coordinate neuroscience product development across agency centers, with an initial focus on Alzheimer’s research.

New framework clarifies review, labeling, and submission requirements for drug-related software and companion apps.

The hospital association called on the FDA to balance patient safety and innovation as it develops a regulatory framework for GenAI medical devices.

An executive order directs new NIH women’s health division and White House task force to accelerate research, care, and clinical adoption.

Medtech trade group outlines recs to improve Medicare’s proposed RAPID coverage pathway and accelerate access to FDA-authorized tech.

FDA aims to accelerate treatments while maintaining safety standards.

AZ argues CMS exceeded authority under the Inflation Reduction Act by grouping separate medicines under a single drug definition.