Business · 21/02/2012Updated: 10/17/2026 · 1 min read
FDA Releases Guidance for Early Clinical Trials with Live Biotherapeutic Products
Summary
The Food and Drug Administration (FDA) has released a guidance document providing recommendations for Investigational New Drug Application (IND) sponsors conducting early clinical trials with live biotherapeutic products (LBPs). The guidance, finalized after a September 2010 draft, became available in February 2012.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →