The US Food and Drug Administration (FDA) kicked off the reauthorization process for the eighth iteration the Prescription Drug User Fee Act (PDUFA VIII) on Monday, with FDA Commissioner Marty Makary ...

Many Department of Health and Human Services (HHS) employees who were placed on administrative leave as part of the Trump administration’s reduction-in-force (RIF) actions earlier this year were ...

PDG said selection of the Korean Pharmacopoeia was a consensus decision that @reflects the quality of the Korean Pharmacopoeia@s application and its alignment with the PDG@s mission to promote global ...

Utah Chapter Event: Potluck in the Park 2025 - Connecting in Nature! Thursday, 31 July 2025 5pm to 8pm Come mingle with your regulatory colleagues and friends in the relaxed atmosphere of Sugarhouse ...

The US Food and Drug Administration (FDA) will not pay performance-based bonuses to employees who are part of several Trump Administration efforts to reduce the federal workforce. The lead federal ...

The top official at the US Food and Drug Administration’s (FDA) drug center is retiring after almost a decade at the agency. On 23 June, Jacqueline Corrigan-Curay, acting director of the Center for ...

Join us for an evening of great conversation, local brews, and networking with fellow regulatory professionals!

The survey also uncovered problems as respondents @highlighted challenges such as the regulatory burden, access to finance and regulatory fees, calling for regulatory simplification and streamlining, ...

The European Commission wants feedback from stakeholders on updating its good manufacturing practice (GMP) guidelines in EudraLex Volume 4 to account for recent advances in artificial intelligence (AI ...

To reduce the risk of aluminum toxicity in infants and adults with impaired renal function, the US Food and Drug Administration (FDA) has issued revised draft guidance to help manufacturers minimize ...

The 18 July 2025, deadline for Health Canada’s mandatory XML Product Monograph (PM) submissions has come and gone — but what has the transition revealed about industry readiness, process challenges, ...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focus: US Moderna gets full US approval for COVID shot in at-risk children 6 months and older (Reuters) US FDA ...