Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications

This guidance implements the electronic submission requirements of section 745A(a) of the FD&C Act for the electronic format of the content submitted in NDsAs, ANDA, certain BLAs, and certain INDs.

Source: FDA Center for Drug Evaluation and Research - What's New - February 19, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news