Abbott Initiates Medical Device Correction for Certain FreeStyle Libre® 3 and FreeStyle Libre 3 Plus Sensors in the U.S.

Unapproved New Drugs/Misbranded Botox

Insights from CDER leadership and experts on public health actions

As defined by FDA, real-world data (RWD) are the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources and real-world evidence (RWE) is the clinical evidence regarding a medical product’s use and potential benefits or risks derived fr

Since the passage of the Prescription Drug User Fee Act (PDUFA) in 1992, user fees have played an important role in expediting the drug approval process while ensuring their safety and efficacy. PDUFA must be reauthorized every five years, and in September 2022, the President signed into law the six

Clinical Outcome Assessments (COA) Qualification Program Submissions

Fresenius Kabi is correcting Ivenix LVP software due to anomalies that could cause serious patient harm or death