FDA’s BTD program facilitates and expedites the development of drugs that receive BTD designation. The agency has authority to grant BTD only to drugs that meet the legal criteria, and periodically assesses whether designated products continue to meet the criteria for BTD. The information supporting FDA’s granting of BTD for a particular drug or biologics may change over time. Some drugs or biologics that appear promising in early development, for example, may not be shown to be safe or effective in later trials. If the BTD designation is no longer supported by subsequent data, FDA may rescind the designation.
For information on the draft guidance and how to comment, please see the Federal Register Notice.
FDA revises 2013 guidance - Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination
Draft Guidance June 2022 FDA is announcing the availability of a draft guidance titled, "Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination." This guidance revises...