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New FDA guidance for industry: ‘‘Bioanalytical Method Validation.’’

Murilo Freitas - 13:16, 22 de May de 20184,209

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.

To access the guidance go to https://www.fda.gov/downloads/Drugs/Guidance/ucm070107.pdf

 
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The Seventy-first World Health Assembly

Murilo Freitas - 10:23, 22 de May de 20181,689

The World Health Assembly The World Health Assembly (WHA) is the decision-making body of WHO.  It is attended by delegations from all WHO Member States and focuses on a specific health agenda prepared by the Executive Board.

The main functions of the World Health Assembly are to determine the policies of the Organization, supervise financial policies, and review and approve the proposed programme budget.

This year’s Health Assembly takes place on 21–26 May 2018 in Geneva, Switzerland.

Live at http://www.who.int/world-health-assembly/seventy-first

World Health +SocialGood: Show schedule

http://www.who.int/world-health-assembly/seventy-first/social-good 

Tuesday, 22 May

Bringing health to all

  • Universal health coverage: what it means and how we can achieve it
  • HIV/AIDS: achievements and challenges
  • Smallpox: the story of eradication

Wednesday, 23 May

Keeping healthy in today’s world

  • Air pollution
  • Transfats
  • Assistive technologies
  • Maternal, child and adolescent health

Thursday, 24 May

Keeping the world safe, serving the vulnerable

  • Ebola in the Democratic Republic of Congo
  • Cox’s Bazar
  • Vaccination to prevent and contain outbreaks
  • EPI: the early days
  • Influenza: prevention and control

For more information about the Seventy-first WHA, go to http://www.who.int/world-health-assembly/seventy-first

 
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COFEPRIS: 10.1 million irregular medical devices insured

Murilo Freitas - 10:54, 21 de May de 2018926

The Federal Commissioner for Protection against Sanitary Risks, Julio Sánchez and Tépoz, reported that so far in this federal administration, COFEPRIS has secured 10.1 million irregular medical devices and seized more than 335 tons of irregular drugs.

More information by the link: https://www.gob.mx/cofepris/articulos/10-1-millones-de-dispositivos-medicos-irregulares-asegurados-cofepris-157511?idiom=es

 
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FDA approves novel preventive treatment for migraine

Murilo Freitas - 10:51, 21 de May de 20181,095

For Immediate Release

May 17, 2018

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.

(…)

For more information go to https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608120.htm

 
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ANMAT: Call for Research Scholarship Contest in Regulatory Science

Murilo Freitas - 10:48, 21 de May de 2018797

The National Administration of Medicines, Food and Medical Technology calls for a scholarship for the granting of a scholarship under the “Research Scholarship in Regulatory Science” approved by Disposition ANMAT 10451/17, on “Obtaining and preclinical evaluation of pharmaceutical nanovehicles for application in the treatment of Chagas disease “.

For more information go to http://www.anmat.gov.ar/comunicados/Llamado_a_Concurso_Beca_5-18.pdf 

 
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FDA MedWatch – Keytruda (pembrolizumab) or Tecentriq (atezolizumab): Decreased Survival in Some Patients in Clinical Trials Associated with Monotherapy

Murilo Freitas - 01:54, 19 de May de 20181,145
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

 
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Report: World health statistics 2018: monitoring health for the SDGs, sustainable development goals

Murilo Freitas - 14:42, 18 de May de 20184,257

Source: World health statistics 2018: monitoring health for the SDGs, sustainable development goals. Geneva: World Health Organization; 2018. CC BY-NC-SA 3.0 IGO.

ISBN: 978-92-4-156558-5

 Published online: May 2018

The World Health Statistics series is WHO’s annual snapshot of the state of the world’s health. This 2018 edition contains the latest available data for 36 health-related Sustainable Development Goal (SDG) indicators. It also links to the three SDG-aligned strategic priorities of the WHO’s 13th General Programme of Work: achieving universal health coverage, addressing health emergencies and promoting healthier populations.

The latest data show that:

:: Less than half the people in the world today get all of the essential health services they need.

:: In 2010, almost 100 million people were pushed into extreme poverty because they had to pay for health services out of their own pockets.

:: 13 million people die every year before the age of 70 from cardiovascular disease, chronic respiratory disease, diabetes and cancer – most in low and middle-income countries.

:: Every day in 2016, 15 000 children died before reaching their fifth birthday.

:: 303 000 women died due to complications of pregnancy or childbirth in 2015. Almost all of these deaths occurred in low- and middle-income countries (99%). Reducing maternal mortality crucially depends upon ensuring that women have access to quality care before, during and after childbirth.

For details and additional information / Más información y material adicional click here.

Full report / Informe completo click here.

 
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