Guidance for Industry on Providing Regulatory Submissions to the Center for Biologics Evaluation and Research in Electronic Format-Lot Release Protocols; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format--Lot Release Protocols" dated July 2006. The guidance is intended to provide manufacturers of biological products regulated by CBER with recommendations for submitting lot release protocols in electronic format to CBER Product Release Branch. This guidance document finalizes the draft guidance entitled "Guidance for Industry: Instructions for Submitting Electronic Lot Release Protocols to the Center for Biologics Evaluation and Research" dated May 1998.