``Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format-Biologics Marketing Applications [Biologics License Application (BLA), Product License Application (PLA)/Establishment License Application (ELA) and New Drug Application (NDA)]''; Availability

概要

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 and Research (CBER) in Electronic Format-Biologics Marketing Applications [Biologics License Application (BLA), Product License Application (PLA)/ Establishment License Application (ELA) and New Drug Application (NDA)].'' The guidance document provides information regarding the electronic submission of license applications, i.e., BLA, PLA/ELA, NDA, and supplements and amendments to those applications intended for submission to Center for Biologics Evaluation and Research (CBER). This guidance document is part of CBER's effort to develop an efficient process for electronic submissions of regulatory information relating to the development and marketing of biological products. Submissions in electronic format are voluntary.