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

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 ...

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 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, ...

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in infants and adults with impaired renal function, the US Food and Drug Administration (FDA) has issued revised draft guidance to help manufacturers minimize ...

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.

In an email to agency staff reviewed by Focus, US Food and Drug Administration (FDA) Commissioner Martin Makary, said he wants to consolidate many of the FDA@s operations to streamline its work. He ...

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 ...