FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: EXPANDED ACCESS TO INVESTIGATIONAL DRUGS FOR TREATMENT USE: QUESTIONS AND ANSWERS; GUIDANCE FOR INDUSTRY; AVAILABILITY

WASHINGTON, Nov. 17 -- Food and Drug Administration has issued a notice called: Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers; Guidance for Industry; Availability.

The notice was published in the Federal Register on Nov. 17 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers." This guidance finalizes the revised draft guidance issued on November 2, 2022, and replaces the final guidance of the same title issued in June 2016 and updated in October 2017. Th...