The US Congressional Budget Office (CBO) says a permanent cut to the National Institutes of Health (NIH) budget and extending drug review times at the Food and Drug Administration (FDA) would likely ...

340 Global Regulators, Health Authorities and Industry Partners Gather in Sydney for Australia Regulatory Device Summit 2025 RAPS Announcements | 21 July 2025 | RAPS ...

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, the ...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focus: US FDA chief’s goals of ‘radical transparency’ threatened by agency cuts (STAT) Eli Lilly drug ...

WASHINGTON @ The US Food and Drug Administration (FDA) plans to make significant updates to its recently launched artificial intelligence (AI) tool Elsa within the next month and has taken critical ...

WASHINGTON @ Marty Makary, commissioner of the US Food and Drug Administration (FDA), said he wants the agency to become nimbler in the next five years to adapt to the fast pace of medical innovation.

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 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 ...

The International Council for Harmonisation (ICH) on Wednesday announced it will develop four new guidelines addressing real-world evidence, comparative efficacy studies, rare disease drug development ...

The US Food and Drug Administration (FDA) has released six warning letters to companies in China, India, Malaysia, and France for significant violations of good manufacturing practice (GMP) ...

Pharmaceutical and medical device manufacturers should not assume that recent staff cuts at the US Food and Drug Administration (FDA) mean the agency will inspect less often and take fewer enforcement ...

Bipartisan members of the Senate Appropriations Committee expressed concern about potential cuts to federal biomedical research funding and their support for stable funding at the National Institutes ...