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.
lunes, 30 de octubre de 2017
MCMi in Action: How FDA works to protect national health and security
Protecting National Health and Security
FDA plays a critical role in protecting the United States from chemical, biological, radiological, nuclear, and emerging infectious disease threats
FDA ensures that medical countermeasures (MCMs)—including drugs, vaccines and diagnostic tests—to counter these threats are safe, effective, and secure.
FDA’s Medical Countermeasures Initiative (MCMi) is an FDA-wide initiative to coordinate MCM development, preparedness and response. FDA helps facilitate development and availability of MCMs by providing scientific and regulatory advice, including during public health emergency situations, like Zika virus outbreaks.
FDA protects the blood supply, and we protect consumers from false product claims and counterfeit products, while communicating and collaborating with U.S. government and international partners, and medical product developers. When necessary, we enable access to investigational MCMs through an appropriate mechanism such as Emergency Use Authorization (EUA).
MCMi in Action - more about how FDA is protecting national health and security
New! November 7, 2017: The Vaccines and Related Biological Products Advisory Committee (VRBPAC) will hold a public meeting (Silver Spring, MD and webcast) to discuss and make recommendations on the clinical development plan for Pfizer's investigational Staphylococcus aureusvaccine intended for pre-surgical prophylaxis in elective orthopedic surgical populations.
November 7-8, 2017:BARDA Industry Day, hosted by HHS/ASPR (Washington, DC) - FDA will present
New! November 9, 2017: FDA Grand Rounds - Assessing the safety and effectiveness of new and emerging therapeutic ultrasound technologies, presented by Greg Clement, PhD, FDA/CDRH
New! November 16, 2017: Public hearing - Devices Referencing Drugs (Silver Spring, MD and webcast) - This hearing will discuss a potential approach for premarket review of medical devices intended for a new use with an approved, marketed drug when the sponsor for the approved drug does not wish to pursue or collaborate on the new use. FDA has outlined a potential approach for premarket review of proposed devices referencing drugs (DRDs) and invites public input on this potential approach during this hearing and through comments to the hearing docket. To attend or present at the hearing, register by October 26, 2017.
Information for industry
FDA's CDRH invites medical device industry, academia, and health care facilities, and others to participate in the 2018 Experiential Learning Program, a formal training program for FDA staff. Submit responses by November 1, 2017, 12:00 p.m. ET.
Draft guidance - Format and Content of a REMS Document (PDF, 166 KB) - This revised draft guidance describes a new recommended format for a Risk Evaluation and Mitigation Strategy (REMS) document, based on extensive stakeholder feedback. This guidance revises and supersedes the draft guidance entitled “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications,” that was published by FDA on October 1, 2009. Comment by December 11, 2017. Related: REMS Basics, REMS@FDA database of approved REMS(October 12, 2017)
Draft guidance - Breakthrough Devices Program (PDF, 257 KB) - This program is intended to help patients have more timely access to devices and breakthrough technologies that provide for more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases, for which no approved or cleared treatment exists or that offer significant advantages over existing approved or cleared alternatives. This guidance describes the policies that the agency intends to use to implement the program. Comment by December 26, 2017. (October 25, 2017)
FDA is requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels. Consumer organizations interested in participating in the selection of consumer representatives should notify FDA in writing. The deadline for both is November 15, 2017.
The National Association of County and City Health Officials (NACCHO) is extending the deadline to submit an abstract for the 2018 Preparedness Summit, which will now close on October 29, 2017 at 11:59 p.m., PT.
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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