Providing regulatory submissions in electronic format — Certain human pharmaceutical product applications and related submissions using the eCTD specifications (In Catapult's regulatory round-up - September 2024)

The FDA has issued a final guidance which describes how sponsors and applicants must organise the content that they submit to the agency electronically for all submission types under section 745A(a) of the FD&C Act. This guidance also references several technical specification documents and the electronic common technical document (eCTD) Technical Conformance Guide, which provides additional details regarding the organization of content for electronic submissions. Text published on the 1st o...