SI
SI
discoversearch

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor.  We ask that you disable ad blocking while on Silicon Investor in the best interests of our community.  If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.
Biotech / Medical : ADVR and ONLY ADVR
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  
To: Bernie Bildman who wrote (31)9/24/2000 5:39:45 PM
From: DAN LITTLE  Read Replies (1) of 278
 
For fast track guidance from the FDA, see URL below. This is good stuff Bernie. I cannot see any reason why Product R would not be fast tracked. It certainly fits within the guidelines, as near as I can tell. What do you think? This also shows that the FDA seems more then willing to work with a company that is Filing for a fast track IND. There are also other programs that CDER offers that should help a company ease through the FDA process. I have to say that I think ADVR is taking advantage of them. Globomax knows the ropes and like you said even has some past FDA employees working for them.

fda.gov

Here is a small section of the above document:

A. Meetings
Appropriately timed meetings between the regulated industry and FDA are a critical aspect of efficient drug development. Sponsors of products in fast track drug development programs should be in regular contact with the appropriate reviewing division to ensure that the evidence necessary to support marketing approval will be developed and presented in a format conducive to an efficient review. Specifically, the following are strongly recommended:

1. Pre-IND consultation so that (i) appropriate preclinical studies can be performed
to demonstrate the potential to address unmet medical needs and to support
introduction of the product into human trials, (ii) phase 1 studies can be optimally
designed to support further product development, (iii) overall development
strategy can be considered, and (iv) issues regarding the potential for fast track
designation may be discussed.

HERE ARE SOME ADDITIONAL SITES

CDER site (FDA guidance page). CDER is a great overall site
fda.gov

This one came from the site above. IND guidance and filing requirements.This is in PDF format.
fda.gov

Keep up with AIDS, and other, trials
actis.org
centerwatch.com
clinicaltrials.gov

Huge medical data base
www-sci.lib.uci.edu
Report TOU ViolationShare This Post
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  

HomeMailHotSubjectMarksPeopleMarksKeepersSettings
Terms Of UseContact UsCopyright/IP PolicyPrivacy PolicyAbout UsFAQAdvertise on SI
© 2026 Knight Sac Media.  Data provided by Twelve Data, Alpha Vantage, and CityFALCON News