More than 30 leading experts and academics in regulatory science and medicine have signed an open letter calling on US Food and Drug Administration (FDA) Commissioner Stephen Hahn to protect the agency from political interference.

A new consensus statement, dubbed the CONSORT-AI extension, lays out the rules of the road for clinical trial reports on interventions involving artificial intelligence (AI). The statement calls on researchers who report on trials that include AI ...

This update includes new entries for PB1046 and galidesivir and updates on dexamethasone, Actemra and convalescent plasma.

The European Medicines Agency (EMA) has issued a new guidelines on registry-based studies, giving detailed advice for use of patient registries in both the pre- and post-authorization phases for medicinal products.

The US Food and Drug Administration (FDA) on Thursday issued three final guidances on its Accreditation Scheme for Conformity Assessment (ASCA) pilot program.