As Marty Makary nears the end of his first month on the job, the FDA Commissioner sat down for two interviews, offering ...

An analysis of 2 pharmacovigilance databases revealed a high prevalence of azacitidine-related adverse events in patients with MDS or AML.

There is no FDA-approved topical formulation of finasteride, and compounded topical finasteride products do not have ...

Research at Taizhou Enze Medical Center in China focused on the risk priority of adverse events during all phases of ...

A thorough adult trauma evaluation used for legal testimony should include a thorough assessment of adverse childhood ...

China is not as big a player in the manufacturing of key ingredients used to make brand and generic medicines as previously ...

Critiques of the vaccine injury reporting system have long been part of Kennedy’s efforts to questions the safety of ...

Kennedy is planning modifications to the Vaccines Adverse Event Reporting System to identify whether vaccines contribute to ...

At a Tuesday event in Indiana, Kennedy pledged to unleash changes to HHS’ Vaccine Adverse Event Reporting System (VAERS), ...

Monitoring of Adverse Event (AE) reporting in clinical trials is important for patient safety. We use bootstrap-based simulation to assign an AE under-reporting probability to each site in a clinical ...

Ensuring the safety of medications doesn't end once they’re approved—it’s an ongoing process that requires careful, continuous monitoring. While clinical trials provide critical data on ...

Maintained by the FDA and Centers for Disease Control and Prevention (CDC), VAERS is a compilation of (unconfirmed) reports of adverse effects ... anyone can submit a report, Marks notes that ...