Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focus: US Medical groups sue HHS, Kennedy over vaccine policy (Reuters) (NYTimes) US FDA approves KalVista's ...

The US Food and Drug Administration (FDA) has published the user fee amounts it will collect in FY2023 from manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices and ...

Many of the concepts and programs the agency discussed with the pharmaceutical industry during the months of reauthorization negotiations have made it into the newly published commitment letter.

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 ...

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, ...

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 ...

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 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 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 ...

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 ...

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in infants and adults with impaired renal function, the US Food and Drug Administration (FDA) has issued revised draft guidance to help manufacturers minimize ...

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 ...