February 5, 2021

REMS Compliance Program

FDA conducts inspections to evaluate compliance with risk evaluation and mitigation strategies (REMS) requirements to ensure the drug’s health benefits outweigh the risks for patients. Inspections […]
February 5, 2021

Coronavirus (COVID-19) Update: FDA Continues Important Work to Support Medical Product Development to Address New Virus Variants

For Immediate Release: February 04, 2021 Statement From: Statement Author Leadership Role Acting Commissioner of Food and Drugs – Food and Drug Administration Janet Woodcock M.D. […]
February 4, 2021

FDA alerts health care professionals and compounders of potential risks associated with the compounding of remdesivir drug products

February 4, 2021 Introduction FDA approved a new drug application (NDA) for Veklury (remdesivir), a drug indicated for adults and pediatric patients (12 years of age […]
February 4, 2021

Rare Disease Therapy Development and Access Remain Top FDA Priorities During COVID-19

Image By: Patrizia Cavazzoni, M.D., Acting Director, Center for Drug Evaluation and Research, and Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research  The […]
February 4, 2021

Xeljanz, Xeljanz XR (tofacitinib): Drug Safety Communication – Initial Safety Trial Results Find Increased Risk of Serious Heart-related Problems and Cancer with Arthritis and Ulcerative Colitis Medicine

[Posted 02/04/2021] AUDIENCE: Patient, Health Professional, Pharmacy, Rheumatology, Gastroenterology, Cardiology, Oncology  ISSUE: The FDA is alerting the public that preliminary results from a safety clinical trial show […]
February 4, 2021

FDA approves Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR)

[7-26-2019] The U.S. Food and Drug Administration has approved new warnings about an increased risk of blood clots and of death with the 10 mg twice […]
February 4, 2021

Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)

FDA previously communicated about the safety clinical trial with Xeljanz, Xeljanz XR (tofacitinib) in February 2019 and July 2019. Drug Safety Communication (PDF – 67KB) 2-4-2021 […]
February 4, 2021

Drug Development Tools | DDTs

DDTs are methods, materials, or measures that can potentially facilitate drug development. FDA established qualification programs to support DDT development. General DDT and Contact Information DDT […]
February 3, 2021

Comunicado de la FDA sobre la seguridad de los medicamentos: La FDA recomienda no usar lidocaína para el tratamiento del dolor por dentición y requiere nuevo Recuadro de advertencia

Anuncio de seguridad [6-26-2014] La Administración de Alimentos y Medicamentos de Estados Unidos (FDA por su sigla en inglés) advirtió que la solución de lidocaína viscosa […]
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