We reviewed postmarketing databases and the published literature on the use of benzodiazepines and associated abuse, misuse, addiction, and physical dependence. In 2019, an estimated 92 […]

We searched the medical literature and the FDA Adverse Event Reporting System (FAERS) for cases of oligohydramnios or neonatal renal dysfunction associated with nonsteroidal anti-inflammatory drug […]

The FDA has issued new information about Xeljanz, Xeljanz XR (tofacitinib) and other Janus kinase (JAK) inhibitors. See the FDA Drug Safety Communication issued on 9-1-2021. […]

FDA reviewed data from case series and prospective and retrospective observational cohort studies over decades of use of statins in pregnant women.1-15 Multiple larger, well-designed, and […]

On This Page Date: September 9, 2024 Time: 9:00 a.m. – 4:00 p.m. ET What is an advisory committee? Advisory committees provide independent expert advice to […]