Sunday, April 20, 2014

FDA Investigational New Drug Application Documents for Cyclodextrin Treatment for Niemann Pick Type C Disease

September 13, 2009 by  
Filed under FDA Cyclodextrin Filings

Cyclodextrin In Infusion BottlesHere you will find detailed documents outlining Addi and Cassi’s cyclodextrin infusion treatments. We filed a compassionate use IND application to the US FDA in early 2009 to give intravenous cyclodextrin treatment which was approved.  In September 2010, FDA approved a new request to put HPBCD directly into the brains of the twins.  Addi and Cassi’s treatment is currently being managed by Dr. Caroline Hastings and Children’s Hospital Oakland and is also monitored by the FDA.

Addi and Cassi’s Intratehcal Cyclodextrin FDA Filings

FDA Filing Requesting To Put Cyclodextrin Into The Brains of the Addi and Cassi – August 2010

Addi and Cassi’s Cyclodextrin Infusion Treatments Submitted to FDA – First Protocol Extension

Dr. Caroline Hastings Submission Letter to FDA – May 2009
Cyclodextrin Protocol Extension Letter To Dr. Ruyi He, Acting Director of FDA
Addi and Cassi Hempel FDA Cyclodextrin IND Extension
Cyclodextrin Specimen Collection Document
Addi and Cassi Hempel BioSampling Protocol

Addi and Cassi’s Compassionate Use IND Documents Submitted To FDA For Cyclodextrin Treatment

FDA Submission Documents for Addi and Cassi’s Cyclodextrin Treatment
Ruyi He FDA response letter to clinical hold – 1-17-09
FDA Type A Meeting Request Letter from Dr. Hastings
FDA Letter Releasing Clinical Hold on Cyclodextrin Treatment For Addi and Cassi Hempel
Hydroxy Propel Beta Cyclodextrin (HPBCD) Summary/Overview
Cyclodextrin Safety Study in Rats and Dogs
PNAS paper by UT Southwestern researchers on cyclodextrin

Article Source

Share this:
  • Print
  • Digg
  • del.icio.us
  • Facebook
  • Google Bookmarks
  • Diigo
  • email
  • PDF
  • Twitter
  • Yahoo! Bookmarks

Comments

5 Responses to “FDA Investigational New Drug Application Documents for Cyclodextrin Treatment for Niemann Pick Type C Disease”
  1. Hi! I just wanted to ask if you ever have any issues
    with hackers? My last blog (wordpress) was hacked and I ended up losing months of hard work due to no back up.
    Do you have any methods to prevent hackers?

  2. Hi friends, its wonderful post about educationand
    entirely explained, keep it up all the time.

  3. Danny says:

    Fine way of telling, and good article to take facts on the topic of my presentation subject matter, which
    i am going to deliver in college.

  4. Very goodd info. Lucky me I found your blog by accident (stumbleupon).

    I’ve book marked it for later!

Trackbacks

Check out what others are saying about this post...
  1. 中山秀征 司会 …

    中山秀征が日テレで司会をするそうですね。私この人があまり好きでないんですけどいろんな局で司会等の仕事してますよね。狙ってるのは堺正章か関口宏の路線なので…



Speak Your Mind

Tell us what you're thinking...
and oh, if you want a pic to show with your comment, go get a gravatar!

CommentLuv Enabled