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, 16 de mayo de 2018
N95 regulation update | Expanding collaborations to improve BSL-4 data quality | New food defense training
FDA exempts certain N95 respirators from premarket notification requirements
Streamlining regulation of PPE essential to public health emergency response
Protecting the health and safety of first responders and healthcare workers is an essential part of planning for public health emergencies. Personal protective equipment (PPE) items such as respirators, protective clothing, and eye protection are standard supplies.
One type of respirator routinely used to protect both the patient and healthcare provider from the transfer of microorganisms, body fluids, and particulate material is known as an N95 respirator(pictured). N95s are single-use, disposable respiratory protective devices.
FDA and CDC’s National Institute for Occupational Safety and Health (NIOSH) share regulatory oversight of N95 respirators. In a final order released on May 16, 2018, FDA is exempting certain N95s from premarket notification [510(k)] requirements, and executing a Memorandum of Understanding with NIOSH.
The final order and MOU streamline the regulation of N95s to help manufacturers easily identify, understand, and work to meet marketing requirements, and help ensure the availability of safe and effective medical products, particularly during times of increased demand, such as a public health emergency. This final action will also decrease regulatory burden on the medical device industry and will eliminate costs required to comply with certain Federal regulations.
Image: N95 face mask respirators. These respirators protect people who wear them by removing contaminants from the air. (Credit: CDC/ Debora Cartagena)
FDA course expands domestic and international collaborations in sixth year
Much of the work to develop medical countermeasures for high-priority agents must be done in high and maximum biosafety level (BSL)-4 laboratories to prevent the agents from being released into the environment, and to provide maximum safety for the scientists.
In another sold-out class, FDA and the University of Texas Medical Branch (UTMB) convened 50 scientists and regulators from industry, academia, and government for an intensive, week-long course on ensuring data quality in maximum-containment labs.
Participants—including public health agency collaborators from eight countries—completed practice exercises while wearing full BSL-4 suits. Interactive lectures and discussions included the challenges of Ebola human clinical trials, the Animal Rule, and best practices to achieve Good Laboratory Practices (GLP) while managing BSL-4 studies.
Image: Course participants on April 26, 2018. In partnership with the National Interagency Confederation for Biological Research (NICBR), the course included lectures and tours at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) and the National Institute of Allergy and Infectious Diseases (NIAID) Integrated Research Facility (IRF) in Frederick, Maryland. (Credit: UTMB)
Save the date!The next course will be held April 8-13, 2019, in Bethesda, MD
Reminder: Laboratory personnel using Zika diagnostic assays under EUA are encouraged to report performance concerns directly to FDA at CDRH-EUA-Reporting@fda.hhs.gov, in addition to reporting concerns to the manufacturer.
New! May 21, 2018: Bio, Chem, and Health Security Luncheon (Washington, DC), 12:00 – 1:30 p.m. ET, hosted by the National Academies of Sciences, Engineering, and Medicine (NASEM) – Greg Measer, regulatory counsel in FDA’s Office of Counterterrorism and Emerging Threats (OCET), will discuss FDA’s initiative to build a national capacity for post-dispensing monitoring and assessment of medical countermeasures. In-person only; registration is required. Related:Medical Countermeasure Monitoring and Assessment
June 25-26, 2018:2018 Center for Biologics Evaluation and Research (CBER) Science Symposium (Silver Spring, MD and webcast) - participants will discuss scientific topics related to the regulation of biologics, and highlight science conducted at CBER by showcasing how scientific research informs regulatory decision-making. Topics include emerging and re-emerging diseases, and new technologies. Register to attend in-person or online by June 18, 2018; early registration recommended because seating and webcast connections are limited.
August 13-14, 2018:Pediatric Medical Device Development public meeting (Silver Spring, MD and webcast), to identify strategies to enhance the medical device ecosystem to cultivate development and innovation of devices that serve the unique needs of pediatric populations. To attend in-person, register by 3:00 p.m. ET August 6, 2018.
In a new Director's Corner Podcast (audio and transcript available), FDA Center for Drug Evaluation and Research (CDER) Director Dr. Janet Woodcock discusses Breakthrough Therapy designation, which is designed to speed drug development and the regulatory review process for promising new therapies. (May 9, 2018)
Advancing the Science of Nanotechnology in Drug Development - The use of nanotechnology in products regulated by the FDA has been ongoing for several decades and has included foods, cosmetics, medical devices and drugs. Within the purview of CDER, there is great diversity in drug products containing nanomaterials. (April 27, 2018)
From HHS/ASPR TRACIE - Mass Distribution and Dispensing of Medical Countermeasures (MCMs) Topic Collection - Provides links to federal, state, local, and tribal programs and resources, lessons learned, plans, tools, and templates, courses, and guidance that can help planners address the need to effectively distribute and administer MCMs to a large number of persons in a short period of time, particularly through mass dispensing efforts led by public health authorities. (May 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 ||