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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 […]
January 8, 2021

Dr. Hahn’s remarks to the Alliance for Health Policy Brazda Breakfast Briefing – 01/08/2021

Speech by Stephen M. Hahn, M.D. Leadership Role Commissioner of Food and Drugs – Food and Drug Administration (Remarks as prepared for delivery) Good morning and […]
January 8, 2021

New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products

Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) […]
January 8, 2021

New Drug Therapy Approvals 2020

IMPACT  INNOVATION  PREDICTABILITY  ACCESSFDA’s Center for Drug Evaluation and ResearchJanuary 2021 Director’s Message Welcome to the FDA’s Center for Drug Evaluation and Research’s (CDER’s) annual report, […]
January 8, 2021

FDA Drug Safety Communication: New information regarding QT prolongation with ondansetron (Zofran)

Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary Safety Announcement [06-29-2012] The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and the […]
January 7, 2021

FDA Drug Safety Communication: FDA warns of serious liver injury risk with hepatitis C treatments Viekira Pak and Technivie

The U.S. Food and Drug Administration (FDA) is warning that hepatitis C treatments Viekira Pak and Technivie can cause serious liver injury mostly in patients with […]
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