This is a study thread and the previous important thread is:...

This is a study thread and the previous important thread is:

http://www.hotcopper.com.au/post_thread.asp?fid=1&tid=58902&sym=EPT#149290

Suggest you start reading that gen. 4 thread first before starting with this one.

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There are a number of key FDA sites and some are:

12.29 The FDA: US Food and Drug Administration
http://www.fda.gov/default.htm

12.29.1 Investigational New Drug (IND) Application Process:
http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm

12.29.2 FAST TRACK, PRIORITY REVIEW AND ACCELERATED APPROVAL: http://www.accessdata.fda.gov/scripts/cder/onctools/Accel.cfm

12.29.3 Orphan Drug Designation.
http://www.fda.gov/orphan/designat/faq.htm


12.29.4 New FDA regulations to ensure supplement purity and quantity of ingredients:
http://www.ozestock.com.au/MessageView.asp?PostID=216092&Symbol=NRT


At the moment EPT is discussing IND items with the FDA: see item 12.29.1.

Gerry