Yearly vaccination still the best way to prevent and control flu outbreaks
On October 24, 2018, FDA approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours. This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years.
Flu season is already well underway. The U.S. Centers for Disease Control and Prevention (CDC) recommends getting vaccinated by the end of October, as seasonal flu vaccine is one of the most effective and safest ways to protect yourself, your family and your community from the flu and serious flu-related complications, which can result in hospitalizations.
November 13-15, 2018: Clinical Investigator Training Course (Silver Spring, MD) - Experts from FDA, the University of Maryland, and the University of Pennsylvania will provide training in all aspects of clinical studies: preclinical and clinical science, statistical structure of trials, ethical requirements, and regulatory considerations. Registration closes on November 6, 2018, or when registration is full.
FDA issued a draft guidance, Considerations for the Development of Dried Plasma Products Intended for Transfusion (PDF, 104 KB). Once finalized, this guidance will provide recommendations to assist manufacturers in the development of dried plasma products, including recommendations regarding starting materials for the preparation of dried plasma products, manufacturing and product quality, product characterization studies, packaging and reconstitution, clinical studies and devices for manufacturing dried plasma. Comment by January 28, 2019.
FDA has published a table of surrogate endpoints that were the basis of drug approval or licensure. This table, which is available as a downloadable spreadsheet, provides valuable information for drug developers on endpoints that may be considered and discussed with FDA for individual development programs. This table also fulfills a 21st Century Cures Act requirement to publish a list of “surrogate endpoints which were the basis of approval or licensure (as applicable) of a drug or a biological product” under both accelerated and traditional approval pathways. Comment by December 31, 2018. (October 30, 2018)
ver historia personal en: www.cerasale.com.ar [dado de baja por la Cancillería Argentina por temas políticos, propio de la censura que rige en nuestro medio]//
weblog.maimonides.edu/farmacia/archives/UM_Informe_Autoevaluacion_FyB.pdf - //
weblog.maimonides.edu/farmacia/archives/0216_Admin_FarmEcon.pdf - //
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