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February 5, 2021

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of All Sterile Compounded Drugs Due to a Potential Lack of Sterility Assurance

Summary Company Announcement Date: May 23, 2019 FDA Publish Date: May 23, 2019 Product Type: Drugs Generic Drugs Reason for Announcement: Recall Reason Description Lack of […]
February 5, 2021

Comunicado de la FDA sobre la seguridad de los medicamentos: La FDA solicita cambios a la etiqueta y empaque de uso único para productos antisépticos tópicos de venta sin receta médica para disminuir el riesgo de infección

Anuncio de seguridad El 13 de noviembre, 2013, La Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) está solicitando cambios […]
February 5, 2021

Comunicado de la FDA sobre la seguridad de los medicamentos La FDA recomienda que no se use Revatio en niños con hipertensión pulmonar

Anuncio de seguridadInformación adicional para pacientesInformación adicional para profesionales de la saludResumen de datosReferencia Anuncio de seguridad 30 de agosto del 2012. La Administración de Alimentos […]
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 […]
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