Zdrowie i gospodarka · 29/03/2002

FDA Releases Guidance for Electronic IND Submissions to CBER

The Food and Drug Administration (FDA) has released a guidance document dated March 2002, providing industry sponsors with information on submitting Investigational New Drug Applications (INDs) in electronic format to the Center for Biologics Evaluation and Research (CBER). This final guidance supersedes a previously announced draft guidance published in the Federal Register on June 1, 1998.