FDA Releases Guidelines for Physicians Using Investigational Drugs in Emergency Situations

In a recent Manual of Policies and Procedures (MAPP), the FDA laid out the process by which physicians can access an investigational drug for treatment in an individual patient in an emergency situation, both during and after normal business hours. MAPP Specifics The MAPP describes the policies and procedures established in the Center for Drug Evaluation and Research (CDER) for managing and processing applications for individual patient expanded access for emergency use (or, emergency investigational new drug applications (EINDs)) for licensed physicians seeking access to an investigational drug for treatment use in an individual patient in an emergency situation, both during and after normal business hours. Although access to an investigational drug for an individual patient in an emergency situation may be requested and authorized through submission of a protocol for such use by an investigational new drug application (IND) holder to its existing IND, this situation is not common and is not addressed in this MAPP. Most emergency access is requested and authorized through submission of a protocol under a new IND (EIND). This scenario (emergency access requested and allowed under an EIND) is addressed in this MAPP. Background On August 13, 2009, FDA published in the Federal Register the final rule “Expanded Access to Investigational Drugs for Treatment Use.” This final rule added subpart I regarding expanded access to investigational new drugs for treatment use into ...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs