FDA issued a guidance for industry entitled ‘‘Bioanalytical Method Validation.’’ This guidance incorporates public comments to the revised draft published in 2013 as well as the latest scientific feedback concerning bioanalytical method validation and provides the most up-to-date information needed by drug developers to ensure the bioanalytical quality of their data.
The Seventy-first World Health Assembly: Interview with Dr. James Fitzgerald, Director of Health Systems and Services PAHO/WHO about Universal health coverage: what it means and how we can achieve it: http://www.who.int/world-health-assembly/seventy-first/social-good
El Comisionado Federal para la Protección contra Riesgos Sanitarios, Julio Sánchez y Tépoz, informó que en lo que va de la presente administración federal, la COFEPRIS ha asegurado 10.1 millones de dispositivos médicos irregulares y decomisado más 335 toneladas de medicamentos irregulares.
The U.S. Food and Drug Administration today approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. The treatment is given by once-monthly self-injections. Aimovig is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks.
La Administración Nacional de Medicamentos, Alimentos y Tecnología Médica convoca a concurso para el otorgamiento de una beca en el marco del programa “Becas de Investigación en Ciencia Reguladora” aprobado por Disposición ANMAT 10451/17, sobre “Obtención y evaluación preclínica de nanovehículos farmacéuticos para aplicación en el tratamiento de la enfermedad de Chagas”.
MedWatch – The FDA Safety Information and Adverse Event Reporting Program
A new MedWatch Safety Alert: Keytruda (pembrolizumab) or Tecentriq (atezolizumab): FDA Alerts Health Care Professionals and Investigators: FDA Statement – Decreased Survival in Some Patients in Clinical Trials Associated with Monotherapy intended for: Oncology, Pharmacy, Risk Manager was just added to the FDA MedWatch Webpage.
You can read the complete MedWatch Safety Alert that includes recommendations at: https://go.usa.gov/xQPtf
In addition to approving the updated prescribing information concerning the gadolinium retention safety issues described in the Drug Safety Communication below, FDA has also approved new patient Medication Guides for all GBCAs.
Health care professionals and patients can access the patient Medication Guides according to the GBCA drug name* on the Medication Guides webpage, or the latest prescribing information by searching in Drugs@FDA.
All MRI centers should provide a Medication Guide the first time an outpatient receives a GBCA injection or when the information is substantially changed. In general, hospital inpatients are not required to receive a Medication Guide unless the patient or caregiver requests it. A health care professional who determines that it is not in a patient’s best interest to receive a Medication Guide because of significant concerns about its effects may direct that it not be provided to that patient; however, the Medication Guide should be provided to any patient who requests the information.†
La Política Nacional de Salud en Cuba le confiere prioridad a la salud como derecho, componente esencial del bienestar humano y objetivo estratégico del desarrollo.
El país dedica esfuerzos y recursos al desarrollo y consolidación del Sistema Nacional de Salud (SNS), caracterizado por los principios de universalidad, gratuidad, accesibilidad, regionalización e integralidad, con alcance a todos los ciudadanos en el campo y la ciudad, y además con una concepción internacionalista.
La atención primaria de salud es la estrategia y el eje fundamental del SNS, que en la actualidad se encuentra inmerso en un proceso de transformaciones con el propósito de continuar avanzando hacia la salud universal, mejorar la salud de la población, incrementar la calidad de los servicios, y hacer más eficientes y sostenibles sus acciones.
Healthcare professionals including family physicians, pediatricians, pharmacists, nurses, nurse practitioners, physicians’ assistants, and those working in travel clinics.
Key messages
This information is applicable to the following vaccines: BOOSTRIX, BOOSTRIX-POLIO, ENGERIX-B, HAVRIX, HAVRIX Junior, INFANRIX-IPV, INFANRIX-IPV/HIB, INFANRIX-hexa, TWINRIX and TWINRIX Junior (see section “Products affected*”).
Leakages have occurred from ceramic coated tip (CCT) syringes used for several GlaxoSmithKline Inc. vaccines in Canada. The leakages occurred at the connection of the syringe tip and the needle hub during vaccine preparation or administration at an approximate rate of 3 per 100,000 syringes distributed. The integrity of the syringe and sterility of the contents were not compromised.
Administration of vaccines from leaking syringes can result in a potential risk of underdosing, that may leave patients inadequately protected from disease after vaccination (see section “Information for healthcare professionals”).
Healthcare professionals are advised:
not to use the syringe when the leakage occurs during reconstitution of lyophilized vaccines.
when the leakage occurs during vaccine injection and the individual received less than the standard dose, the decision to revaccinate should take into account both the potential benefits and risks associated with administering a repeated dose (see section “Information for healthcare professionals”).
GlaxoSmithKline Inc. has been working with Health Canada to provide information regarding the leaking syringes for vaccines and the corrective actions implemented. The introduction of improved CCT syringes on the Canadian market is anticipated in 2018. However, both improved and affected CCT syringes are expected to be on the market until the end of 2019, the estimated time for using up the potentially affected syringes.
Issue
There have been reports of leakage from CCT syringes used for several GlaxoSmithKline Inc. vaccines during vaccine preparation or administration. Although the leakage does not pose a concern for the vaccine sterility, there is a potential risk of underdosing associated with administration of a vaccine from a leaking syringe that may leave patients inadequately protected from disease after vaccination.
