Biocon Biologics Limited - 7/26/2024
Biocon Biologics Limited - 7/26/2024
FDA warns consumers not to purchase or use Umary and Amazy products as they may be harmful to your health
FDA is warning consumers not to purchase or use Umary and Amazy products, marketed as dietary supplements, as they may be harmful to your health. This is due to potentially dangerous hidden drug ingre
FDA warns consumers not to purchase or use Umary and Amazy products as they may be harmful to your health
FDA is warning consumers not to purchase or use Umary and Amazy products, marketed as dietary supplements, as they may be harmful to your health. This is due to potentially dangerous hidden drug ingre
New Drugs Regulatory Program Modernization: Integrated Assessment of Marketing Applications and Integrated Review Documentation
View details about the NDRP Modernization: Integrated Assessment of Marketing Applications and Integrated Review Documentation; Request for comments
New Drugs Regulatory Program Modernization: Integrated Assessment of Marketing Applications and Integrated Review Documentation
View details about the NDRP Modernization: Integrated Assessment of Marketing Applications and Integrated Review Documentation; Request for comments
Youth E-Cigarette Use Drops to Lowest Level in a Decade
Today, the FDA and CDC released new data from the National Youth Tobacco Survey, including findings on e-cigarette and nicotine pouch use among U.S. youth
September 5, 2024
Today, the FDA and CDC released new data from the National Youth Tobacco Survey, including findings on e-cigarette and nicotine pouch use among U.S. youth
Ventilator Correction: Breas Medical Updates Use Instructions for Vivo 45 LS due to Potential Elevated Formaldehyde Levels in Newly Manufactured Ventilators
Vivo 45 LS ventilators support breathing in homes and health settings. New devices may expose users to elevated formaldehyde levels for a short time.
Continuous Glucose Monitoring (CGM) Sensor Recall: Abbott Diabetes Care Inc Issues Recall for Certain FreeStyle Libre 3 Sensors due to Risk for Inaccurate High Glucose Readings
FreeStyle Libre 3 sensor provides continuous monitoring of glucose levels but a small number of sensors may give inaccurate high readings
Laryngoscope Recall: Medtronic Removes Certain McGrath MAC Video Laryngoscopes, Updates Use Instructions for Others due to Increased Risk for Battery Overheat and Explosion
McGrath MAC Video Laryngoscopes help visualize the trachea and larynx. The batteries on these devices may deplete too much, causing overheating and explosion.
CDER Nitrosamine Impurity Acceptable Intake Limits
Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs); Updated Information
Smiths Medical Issues Urgent Medical Device Notification Informing Customers of a Potential Issue with Certain Bivona® Tracheostomy Tubes
Smiths Medical issued an Urgent Medical Device Notification on May 29, 2024, to notify affected customers of a potential issue with certain Bivona® Tracheostomy Tubes
Lung Therapy Component Recall: Baxter Healthcare Corporation Recalls Certain Volara System Single-Patient Use Circuits and Blue Ventilator Adapter Assemblies Due to Disconnection Risk That May Prevent Proper Ventilation
The Volara System provides lung therapy for patients on ventilators but some single-patient use circuits and blue ventilator adapter assemblies may disconnect.
Mother Stem Institute, Corp. - 680118 - 08/20/2024
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Prescriber Perceptions of Boxed Warnings: A Qualitative study
CDER research finds that boxed warnings are only one of several factors that influence prescriber treatment decisions.
Transcript: Angiotensin II Receptor Blockers (ARBs) - A Message for Patients
Transcript: Angiotensin II Receptor Blockers (ARBs) - A Message for Patients
La FDA autoriza la vacuna contra el COVID-19 de Novavax actualizada para brindar una mejor protección contra las variantes que circulan actualmente
La FDA autorizó para uso de emergencia la vacuna contra el COVID-19 de Novavax actualizada (fórmula 2024-2025) con el fin de atacar más de cerca las variantes que circulan actualmente y brindar una me
Oncologic Drugs Advisory Committee Charter
This is the Charter for the Oncologic Drugs Advisory Committee.