Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information " dated February 2012. The guidance provides certain Investigational New Drug Application (IND) sponsors with recommendations in connection with the submission of INDs for early clinical trials with live biotherapeutic products (LBPs). The guidance announced in this notice finalizes the draft guidance of the same title dated September 2010.