The “Expanded Access to Investigational Drugs for Treatment Use, Proposed Rule” recommends amending regulations on access to investigational new drugs for the treatment of patients. It would clarify existing regulations and add new types of expanded access for treatment use. Under the proposal, expanded access to investigational drugs for treatment use would be available to individual patients, including in emergencies; intermediate-size patient populations; and larger populations under a treatment protocol or treatment investigational new drug application. It is intended to improve access to investigational drugs for patients with serious or immediately life-threatening diseases or conditions, who lack other therapeutic options and who may benefit from such therapies. There is a 90-day public comment period provided in this propose rule. If any consumer wants to comment, you have until March 14, 2007, here is the link: http://www.accessdata.fda.gov/scripts/oc/dockets/comments/COMMENTSMain.CFM?EC_DOCUMENT_ID=1354&SUBTYP=CONTINUE&CID=&AGENCY=FDA Ann Fonfa's Comments to FDA: Access to DrugsStatement submitted February 15, 2007 Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.