The publication of this first book addressing global regulation of regenerative medicines marks a seminal moment in the evolution of the regenerative medicine industry. By compiling all the relevant ...

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, FDA ...

As an example of how AI tools could be used to regulate in real time, Walsh said that the fastest way they've been able to output studies from FDA's Sentinel Initiative, which tracks safety reports ...

Makary said some operational subject matter experts at FDA will be temporarily reassigned to the Office of Operations and will help the agency figure out how to make it more integrated and agile.

Makary and Prasad recently signaled their interest in bringing products more quickly to market through more streamlined pathways in a roundtable meeting with stakeholders discussing cell and gene ...

Stakeholders say they want lower regulatory hurdles for cell and gene therapy (CGT) products, including streamlined pathways. Some researchers said updates to the US Food and Drug Administration@s ...

The US Food and Drug Administration (FDA) has launched a new artificial intelligence (AI) tool nearly one month ahead of schedule that the agency says significantly improves operations and is aimed at ...

Singapore’s Health Sciences Authority (HSA) is running a consultation into plans to exempt more types of artificial intelligence (AI)-software as a medical device (SaMD) products from its license and ...

The Trump Administration is seeking $6.8 billion to fund the US Food and Drug Administration (FDA) in FY 2026 – an 11.5 percent cut from its current budget authority – with the agency looking to ...

ICH also touted its Q1 guideline on stability testing of drug substances, which was released for comment after reaching Step 2a/b in April just before the Madrid meeting, as well as its final E6 (R3) ...

Editor's note: This article was updated on 16 May 2025 to clarify FDA Commissioner Martin Makary's statements about vaccines. Leveraging artificial intelligence in product reviews and postmarketing ...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focus: US In combative hearings, Kennedy defends HHS cuts, backtracks — and lashes out (STAT) Former FDA head ...