The US Food and Drug Administration (FDA) announced plans to implement AI tools throughout the agency to assist in conducting scientific reviews following the successful completion of a pilot program ...

As the reality of the Trump administration@s return-to-office (RTO) policy settles in, some US Food and Drug Administration (FDA) staff are looking for new jobs or are taking buyout offers from the ...

As the drug pricing debate on Capitol Hill continues, the debate over how biopharma companies spend also continues, though perhaps more quietly. @ ...

Top US Food and Drug Administration (FDA) officials have outlined the agency@s plans to reform its human foods program and transform its Office of Regulatory Affairs (ORA) into the Office of ...

The US Food and Drug Administration (FDA) has released a draft guidance outlining the purpose and content of a use-related risk analysis (URRA) for drug- and biologic-led combination products.

The European Medicines Agency (EMA) is proposing to waive comparative efficacy studies (CES) for biosimilars with a straightforward mechanism of action (MOA), such as monoclonal antibodies and ...

This conference will provide you with the latest practical tools, networking opportunities, and insights that can be directly applied to enhance your regulatory strategy on a global scale.

The European Medicines Agency (EMA) want to set clear quality guidelines for drug companies manufacturing synthetic peptides and oligonucleotides.