FDA Provides Guidelines for Expanded-Access Applications

The FDA released a guide for physicians detailing how to apply for expanded access to drugs for individual patients in non-emergency situations.

The first step is to ask the drug’s manufacturer to authorize references to information in the pending application for approval of the drug — or, failing that, to provide other evidence of the drug’s quality. The last step is obtaining the patient’s informed consent.

The FDA also provided information on how to report the results of the treatment, including adverse effects.