Illinois Bans AI Therapy: What It Means for the Future of Mental Health Apps  

Artificial intelligence is transforming healthcare, with the FDA approving digital apps for conditions like ADHD. But when it comes to mental health therapy, Illinois has drawn a firm line—banning AI-driven psychotherapy in favor of licensed professionals. This pivotal decision raises crucial questions about the safety, ethics, and regulatory future of AI mental health apps. Artificial … Read more

New Regulatory Strategy for Ultra-rare Disease Products

Developing treatments for ultra-rare diseases has always been one of the toughest challenges in drug development. With small patient populations and limited trial options, many promising therapies stall before reaching patients. The FDA’s new Rare Disease Evidence Principles (RDEP) aim to change that by offering a clearer, faster, and more flexible path to approval. This … Read more