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2018 Center for Biologics Evaluation and Research Science Symposium [USFDA-CBER]

The Food and Drug Administration (FDA) is announcing the following public symposium entitled ‘‘2018 Center for Biologics Evaluation and Research Science Symposium.’’ The purpose of the public symposium is to discuss scientific topics related to the regulation of biologics and highlight science conducted at the Center for Biologics Evaluation and Research (CBER) by showcasing how scientific research informs regulatory decision making and to provide a forum for developing collaborations within FDA and with external organizations. The symposium will include presentations by experts from academic institutions, government agencies, and research institutions.

DATES

The public symposium will be held on June 25 and 26, 2018, from 9 a.m. to 3 p.m.

 

TOPICS FOR DISCUSSION

The public symposium will include presentations on the following topics:

(1) Emerging and re-emerging diseases;

(2) diverse types of data in regulatory decision making;

(3) immune response to vaccination;

(4) immunotherapy;

(5) new technologies for research and treatments; (6) the role of the microbiome in human disease; and

(7) regenerative medicine.

 

PARTICIPATON

Participating in the Public Symposium could be in person or by webast.

Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public symposium (either in person or by webcast) (see Streaming Webcast of the Public Symposium) must register online by June 18, 2018, midnight Eastern Time. Early registration is recommended because seating is limited. There will be no onsite registration; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted.

For more information go to https://www.gpo.gov/fdsys/pkg/FR-2018-03-22/pdf/2018-05805.pdf

 

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

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

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

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

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

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

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