fbpx
January 11, 2021

UPDATED TIME AND MEETING MATERIALS INFORMATION: October 8, 2020 Joint Meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM) Meeting Announcement – 10/08/2020 – 10/08/2020

On This Page Date: October 8, 2020 Time: 10:00 AM – 5:00 PM ET UPDATED INFORMATION (as of September 24, 2020): The meeting time has changed […]
January 11, 2021

Warning Letters and Notice of Violation Letters to Pharmaceutical Companies

CDER Warning Letters notify manufacturers of significant violations of FDA regulations. CDER works with the company to ensure correction.
January 11, 2021

Warning Letters 2021

Office of Prescription Drug Promotion Office of Compliance/Immediate Office  Office of Manufacturing Quality Office of Scientific Investigations Office of Unapproved Drugs and Labeling Compliance Coco’s Holistic […]
January 11, 2021

Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present

Drug Sponsor Medical Review Clinical Pharmacology Review Statistical Review BPCA or PREA or Both Abacavir and Lamivudine – Epzicom ViiV Healthcare Company Medical (PDF – 2.8 […]
January 8, 2021

Fresenius Kabi Issues Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate Matter

Summary Company Announcement Date: January 08, 2021 FDA Publish Date: January 08, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of particulate matter […]
January 8, 2021

Comunicado de la FDA sobre la seguridad de los medicamentos: El uso de codeína en ciertos niños tras amigdalectomía y/o adenoidectomía puede llevar a eventos adversos poco comunes pero que pueden poner en peligro la vida o causar la muerte

Anuncio de seguridadInformación adicional para pacientes y cuidadoresInformación adicional para profesionales de la saludResumen de datos Cuadro 1. Prevalencia de metabolizadores ultrarrápidos en diferentes grupos demográficos […]
January 8, 2021

Comunicado de la FDA sobre la seguridad de los medicamentos: Casos poco comunes de quemaduras graves con el uso de analgésicos tópicos de venta libre para el dolor muscular y articular

Anuncio de seguridadInformación adicional para consumidoresInformación adicional para profesionales de la saludResumen de datosFuentes Anuncio de seguridad 13 de septiembre del 2012. La Administración de Alimentos […]
January 8, 2021

Better Data for a Better Understanding of the Use and Safety Profile of Cannabidiol (CBD) Products

Image By: Stephen M. Hahn, M.D., Commissioner of Food and Drugs and Amy Abernethy, M.D., Ph.D., Principal Deputy Commissioner Over a short period of time, our […]
January 8, 2021

2020: A Strong Year for New Drug Therapy Approvals – Despite Many COVID-19 Challenges

Image By: Patrizia Cavazzoni, M.D., Acting Director, Center for Drug Evaluation and Research Throughout 2020, the U.S. Food and Drug Administration’s Center for Drug Evaluation and […]
google.com, pub-5711488453051849, DIRECT, f08c47fec0942fa0