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FDA – Deeper Dive Webinar: Postmarketing Drug Safety and Inspection Readiness – June 19, 2018

Murilo Freitas - 10:18, 14 de junio de 2018588

The Food and Drug Administration, Center for Drug Evaluation and Research and Small Business and Industry Assistance (CDER SBIA), welcomes you to our webinar series.

Tuesday, June 19, 2018
10:00am – 2:00pm (Eastern)

For more information go to https://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm608748.htm 

 
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FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment

Murilo Freitas - 10:14, 14 de junio de 2018833

June 4, 2018

The U.S. Food and Drug Administration today approved Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim) to decrease the chance of infection as suggested by febrile neutropenia (fever, often with other signs of infection, associated with an abnormally low number of infection-fighting white blood cells), in patients with non-myeloid (non-bone marrow) cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia.

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For more information go to https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609805.htm

 
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CECMED observador ICH

Murilo Freitas - 10:05, 14 de junio de 2018718

El  CECMED participó por segunda vez en su condición de Observador en la Asamblea del actual Consejo Internacional para la Armonización de los Requerimientos Técnicos de Productos Farmacéuticos de Uso Humano, (ICH) celebrada esta vez en Montreal, Canadá, del 31 de mayo al 1 de junio. Allí compartió con la membrecía, representantes de la industria, de organismos internaciones, grupos de trabajo y con las otras ocho Autoridades Reguladoras de Medicamentos que integran ICH, siguiendo el programa establecido.

más informaciones por el enlace http://www.cecmed.cu/content/cecmed-observador-ich

 
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Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals – Adverse Events After Receiving Eye Injections

Murilo Freitas - 01:00, 14 de junio de 2018564
At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields.
FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared in-house samples of Guardian’s product and found that autoclaving and sonication caused the poloxamer 407 to degrade. The amount of poloxamer 407 in Guardian’s product (12%, g/100 mL) is much greater than the maximum amount of poloxamers in FDA-approved ophthalmic products for topical administration (0.1-0.2%, g/100 mL), and the safety profile of drug products intended for intravitreal injection containing poloxamer 407 is unknown.

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm610835.htm

 
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Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals – Adverse Events Reported After Receiving Eye Injections

Murilo Freitas - 01:00, 14 de junio de 2018595
At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields.
FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared in-house samples of Guardian’s product and found that autoclaving and sonication caused the poloxamer 407 to degrade. The amount of poloxamer 407 in Guardian’s product (12%, g/100 mL) is much greater than the maximum amount of poloxamers in FDA-approved ophthalmic products for topical administration (0.1-0.2%, g/100 mL), and the safety profile of drug products intended for intravitreal injection containing poloxamer 407 is unknown.

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm610835.htm

 
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