aportes a la gestión necesaria para la sustentabilidad de la SALUD PÚBLICA como figura esencial de los servicios sociales básicos para la sociedad humana, para la familia y para la persona como individuo que participa de la vida ciudadana.
miércoles, 31 de enero de 2018
Register now for data quality in BSL-4 labs course | Learn about biosimilars | Auto-injector EUA update
Course designed for researchers who conduct studies to support approval under the Animal Rule
Early registration is recommended, as this course quickly fills to capacity. FDA sponsors this course as part of our work to advance the development and availability of medical countermeasures. There is no registration cost. Register by February 16, 2018.
Image: Course attendees participate in lectures and hands-on activities during previous courses. More course photos are available on Flickr.
New biosimilar resources
Have questions about biosimilars? Check out FDA’s new biosimilar resources – they include biosimilar definitions, information about prescribing them, and details on their rigorous approval standards.
Image: FDA approves a biosimilar after rigorous evaluation. All biosimilars meet FDA's rigorous standards for approval, are manufactured in FDA-licensed facilities, and are tracked as part of post-market surveillance to ensure continued safety.
January 24, 2018: In response to CDC's request, FDA concurred (PDF, 33 KB) with amendments to the Rafa Atropine Auto-Injector EUA (1) to clarify that the authorized product (0.5 mg, 1 mg, and 2 mg) may be administered through clothing, and (2) for changes to certain Rafa-planned manufacturing processes. The Rafa Atropine Auto-Injector was initially authorized for emergency use for initial treatment of nerve agent or certain insecticide (organophosphorus and/or carbamate) poisoning in April 2017. Additional information, including updated fact sheets
New! February 12, 2018: HHS Tick-Borne Disease Working Group meeting (webcast), 12:00 - 4:00 p.m. ET - For this third meeting, the Working Group will focus on mapping out the work of the six Subcommittee Meeting Working Groups that were established on December 12, 2017. Additional information, including how to attend, will be posted to the Working Group web page one week before the meeting.
April 17-20, 2018: Preparedness Summit (Atlanta, GA) - The theme for the conference is Strengthening National Health Security: Mastering Ordinary Responses, Building Resilience for Extraordinary Events. Registration is now open. (fee)
FDA released draft guidance on its policies and procedures related to the designation of a qualified infectious disease product (QIDP) under the Generating Antibiotic Incentives Now (GAIN) Act: QIDP Designation Questions and Answers (PDF, 390 KB). Comment by April 2, 2018. (January 29, 2018)
The FDA Office of Pharmaceutical Quality (OPQ) released a new white paper (PDF, 461 KB) on how sponsors can improve the use of a Quality Overall Summary (QOS) submitted as part of drug marketing or licensing applications.(January 23, 2018)
CDC has released a new app for bioterrorism responders, Field Facts (screenshot at right), which provides fast access to information during a possible bioterrorism response. Available for Apple and Android. (January 17, 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 - //
www.proz.com/kudoz/english_to_spanish/art_literary/523942-key_factors.html - 65k - // www.llave.connmed.com.ar/portalnoticias_vernoticia.php?codigonoticia=17715 // www.frusculleda.com.ar/homepage/espanol/activities_teaching.htm // http://www.on24.com.ar/nota.aspx?idNot=36331 ||