Summary Company Announcement Date: February 13, 2025 FDA Publish Date: February 14, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Bags of POTASSIUM CHLORIDE […]

[2/14/2025] FDA’s Center for Drug Evaluation and Research (CDER) has a qualifying tool to support the development of treatments for alcohol use disorder (AUD). Innovation in treatment […]

Description:  The HL7 Individual Case Safety Report (ICSR) captures information needed to support reporting of adverse events, product problems and consumer complaints associated with the use […]

Image Español Clinical trials help provide reliable evidence needed when studying medical products to diagnose, prevent, treat, and sometimes even cure, childhood diseases. Children who participate […]

Image CaptionAttendees participate in this annual training course where they learn best practices for ensuring data quality and integrity in BSL-4 facilities. Current course | Background […]

Summary Company Announcement Date: July 29, 2023 FDA Publish Date: July 31, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Out of Specification Results […]

Exceptions or additions to the recognized standards For the bacteria listed below, susceptibility test interpretive criteria are not recognized at this time: Acinetobacter spp Other Non-Enterobacterales […]

Exceptions or additions to the recognized standards   Minimum Inhibitory Concentrations(mcg/mL) S I R Neisseria gonorrhoeae – ≤1 ≥2 Abbreviations: S = Susceptible; I = Intermediate; […]

Exceptions or additions to the recognized standards   Minimum InhibitoryConcentrations(mcg/mL) Disk Diffusion(zone diameter in mm) Pathogen S I R S I R Enterobacterales ≤8  – ≥16 […]