FDA BRIEF: Week of October 17, 2016 

Voice


 21 FDA grants to stimulate product development for rare diseases

Image result for Rare Disease image

 

AWARD of 21 new clinical trial research grants totaling > $23 million over 4 years

  • Boost development of products for rare diseases
  • To Principal Investigators from academia and industry (drugs and devices)
  • For 21 different rare diseases with little or no available treatment
  • Through the Orphan Products Clinical Trials Grants Program
  • For clinical studies evaluating product safety and effectiveness contributing to FDA approval

FUNDING

  • 24  % for cancer particularly devastating brain cancer
  • 43% for  pediatric patients as young as newborns
  • 1 medical device for neuroprosthesis
  • Funding rate: 31%

READ


Introducing FDA’s Emerging Sciences Idea Portal: Please Help Us Predict the Future

By: Donna L. Mendrick, Ph.D., Associate Director for Regulatory Activities, NCTR

Donna Mendrick

EMERGING SCIENCES WORKING GROUP formed in 2015

  • Representatives from FDA product and research centers & offices
  • Leverage scientific expertise and resources to conduct long-range horizon scanning
  • Emerging issues and cross-cutting scientific advances
  • FDA preparedness to proactively address  emerging issues and scientific advances

GOAL

  • Identify areas not yet addressed in current products e.g. brain-computer interfaces
  • Develop science-based planning, programs, policies, reporting, communication

EXPERTISE

  • Cast a wide net – Within and outside FDA
  • Experts in  private sector

PORTAL

  • For science and technology experts outside of government
  • Submit predictions on the next new things in their field of specialization – will barely show up on a web search
  • NOT looking for advances that are already under discussion.

 

READ


New FDA/EMA rare diseases and patient engagement clusters underway

by:

Jonathan C. Goldsmith, M.D., FACP, Associate Director, Rare Diseases Program, CDER

Sandra Kweder, M.D., Deputy Director, EU Office, EMA Liaison

Dr. Jonathan Goldsmith

Sandra Kweder

GLOBAL COLLABORATION

  • FDA collaborates with other countries and international regulatory agencies for global development programs
  • European Medicines Agency (EMA) is valuable collaborator : 4,500 scientists, supervises medicines for > 500 million people in 31 countries

FDA-EMA COLLABORATION

  • > 10 years
  • Work in groups called “clusters”
  • Summarized in EMA website.

RECENT CLUSTER:RARE DISEASE

  • To advance treatments for patients with rare diseases
  • Share information and review aspects of rare disease drug development programs
  • Identification and validation of trial end points
  • Potential trial designs
  • Flexibility in evaluation of drug development programs
  • Expediting review and approval

RECENT CLUSTER: PATIENT ENGAGEMENT

  • Incorporate the patient’s involvement and viewpoint in the drug development process
  • Develop common goals of expanding patient engagement activities
  • Finding patients as spokespersons
  • Train selected patients to effectively participate in agency activities
  • Report impact of patient involvement

READ


 FDA & NAtional Cyber Security Awareness Month

Image result for national cybersecurity awareness image

National Cybersecurity Awareness Month. Proclaimed by President Obama each year

FDA POSITION:

  • Medical device cyber safety is large and shared responsibility
  • Requires diligence from all stakeholders: manufacturers, government agencies, health care organizations, health care professionals, cybersecurity researchers, and medical device user

FDA PARTNERSHIPS:

  • Public and private sector organizations
  • Department of Health and Human Services, National Health Information Sharing and Analysis Center (NH-ISAC), Medical Device Innovation, Safety, and Security Consortium (MDISS), Department of Homeland Security’s Industrial Control Systems Cyber Emergency Response Team (ICS-CERT)

FDA RECOMMENDATIONS: Employing cybersecurity best practices and good cyber hygiene

RESOURCES: Stop.Think.Connect.™ campaignCDRH website.

Are you safe online? Visit the online resource guide to find out. Brought to you by DHS Stop.Think.Connect.


 

 

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