FDA acts on requests for expanded access when submitted by a sponsor or by a third party with the sponsor's support. The agency approved 99.4% of expanded access applications submitted from October 2009 to September 2013. The agency did not deny any requests to amend existing INDs, which FDA calls expanded access protocols.FDA denied only 24 of the 3,792 requests it received for an expanded access IND, which is used when there is no existing IND that can be amended, or when a sponsor with an existing IND declines to be the sponsor for expanded access. For example, a company may ask a physician to serve as the sponsor of an expanded access IND. Of the 24 requests for expanded access INDs that FDA did not permit to proceed, 21 were applications for emergency use. Emergency INDs and protocols can be approved rapidly for a single patient without a written request. Intermediate-size INDs and protocols cover up to 100 patients; treatment INDs and protocols are for more than 100 patients. For the time periods below, 2010 and 2011 represent the years ended Oct. 12, while 2012 and 2013 are for the years ended Sept. 30. Source: FDA