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

The Indian government has strengthened oversight of cell and gene therapies by bringing the novel modalities into the ...

Industry and academic stakeholders have asked the US Food and Drug Administration (FDA) to clarify its objectives and plans for a proposed pilot program to evaluate how artificial intelligence (AI) ...

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. This week, ...