The Food & Drug Administration (FDA) has recently released a Manual of Policies and Procedures (MAPP) for the use of an investigational drug in an emergency – whether during or outside business hours. Because of the urgent nature of these requests, the FDA reviews the applications as soon as they’re received. Also, because this process includes the need for the drug maker to give permission as well, the physician submitting the application to the FDA must include the letter of permission from the pharmaceutical company. To learn more: